During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Ivoclar Vivadent
Class I - Dangerous
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
IgE Calibrator Series
Randox Laboratories
Class I - Dangerous
According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.
Class I - Dangerous
Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.
Class I - Dangerous
R&D Systems, Inc. received two customer complaints that results of the Controls provided with the Quantikine¿ IVD¿ Human sTfR Immunoassay kit were out of the range high. Internal testing within R&D Systems confirmed a problem with Control results being out of range high.
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Spacelabs Healthcare
Class I - Dangerous
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
Syngo.plaza, Picture Archiving and Communication System
Siemens Medical Solutions USA
Class I - Dangerous
Software upgrade to eliminate several issues
Class I - Dangerous
Product gives incorrect low blood glucose levels.
Class I - Dangerous
In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.
Class I - Dangerous
Product gives incorrect low blood glucose levels.
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
Class I - Dangerous
Software patch installation to address several safety issues.
Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Siemens Healthcare Diagnostics
Class I - Dangerous
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
Class I - Dangerous
Product gives incorrect low blood glucose levels.
Class I - Dangerous
Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.
Administration Set potential filter leaking
Administration Set potential filter leaking
Administration Set potential filter leaking
Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
Class I - Dangerous
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.