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Diagnostic Equipment

🏥 Medical Devices • 6,627 recalls

ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Instrumentation Laboratory

Class I - Dangerous

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Jul 19, 2013 Diagnostic Equipment Nationwide View Details →

ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Instrumentation Laboratory

Class I - Dangerous

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Jul 19, 2013 Diagnostic Equipment Nationwide View Details →

Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens.

Assuramed

Class I - Dangerous

The products may have been stored at temperatures outside their required storage conditions.

Jul 16, 2013 Diagnostic Equipment Nationwide View Details →

ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Instrumentation Laboratory

Class I - Dangerous

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Jul 19, 2013 Diagnostic Equipment Nationwide View Details →

GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.

GE Healthcare

Class I - Dangerous

GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.

Jul 12, 2012 Diagnostic Equipment Nationwide View Details →

ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Instrumentation Laboratory

Class I - Dangerous

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Jul 19, 2013 Diagnostic Equipment Nationwide View Details →

ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

Instrumentation Laboratory

Class I - Dangerous

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

Jul 19, 2013 Diagnostic Equipment Nationwide View Details →

Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.

Integra LifeSciences Corp. d.b.a. Integra Pain Management

Class I - Dangerous

Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.

Sep 4, 2013 Diagnostic Equipment Nationwide View Details →

Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.

Xlumena

Class I - Dangerous

A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.

Apr 17, 2013 Diagnostic Equipment View Details →

Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.

Medical Indicators

Class I - Dangerous

TempaDot products may have been mislabeled.

Jul 10, 2013 Diagnostic Equipment Nationwide View Details →

ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

Siemens Healthcare Diagnostics

Class I - Dangerous

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Jul 25, 2013 Diagnostic Equipment Nationwide View Details →

ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

Siemens Healthcare Diagnostics

Class I - Dangerous

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Jul 25, 2013 Diagnostic Equipment Nationwide View Details →

KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas¿ HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas¿ HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas¿ HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas¿ HPV Test include the following liquid based collection media and collection device: " ThinPrep¿ Pap TestTM PreservCyt¿ Solution " Endocervical Brush/Spatula

Roche Molecular Systems

Class I - Dangerous

During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina

Jul 25, 2013 Diagnostic Equipment Nationwide View Details →

ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.

Siemens Healthcare Diagnostics

Class I - Dangerous

Calibration failures and/or significant negative shifts in quality control (QC) and patient results.

Jul 25, 2013 Diagnostic Equipment Nationwide View Details →

HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

HemoCue AB

Class I - Dangerous

During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.

Jul 15, 2013 Diagnostic Equipment Nationwide View Details →

"Flo Trac Sensor Model MHD85" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.

Edwards Lifesciences

Class I - Dangerous

The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.

Jul 31, 2013 Diagnostic Equipment Nationwide View Details →