Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
Siemens Healthcare Diagnostics
Class I - Dangerous
Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.
Class I - Dangerous
As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
Class I - Dangerous
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Terumo Cardiovascular Systems
Class I - Dangerous
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are tested on certain systems or come into contact with bleach they can produce cyanide gas. The solution in these tubes contains guanidine thiocynate and may put laboratory personnel at risk of exposure to cyanide gas when it comes into contact with bleach or reagents containing bleach.
Class I - Dangerous
The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
RANDOX LABORATORIES
Class I - Dangerous
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Class I - Dangerous
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.
Class I - Dangerous
Incorrect expiration date included in test kit labeling and/or in Substrate component label.
Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Roche Diagnostics Operations
Class I - Dangerous
Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.
Terumo Cardiovascular Systems
Class I - Dangerous
Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
RANDOX LABORATORIES
Class I - Dangerous
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Class I - Dangerous
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Class I - Dangerous
Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.
MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip System Package Insert with the most recent revision (150803-8).
Class I - Dangerous
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
Class I - Dangerous
US-dates between the product package label and the bar code display.