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All product recalls associated with bioMerieux Inc.
Total Recalls
161
Past Year
1
Class I (Serious)
0
Most Recent
Jun 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's
The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.
A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
The ISI labeling for Simplastin HTF on the Coag-a-Mate MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.
Over heating of memory board.
Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
Complaints were received from the field regarding prolonged clot times, high control values and erratic results.
The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.
The product may give false positive results.
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
Instrument malfunction. Electrical short circuit may occur resulting in damage or a fire hazard.
Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly.
The cards were stamped with an incorrect card code that causes the system to read and analyze the cards incorrectly.
Kit may contain incorrect components
Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The 'list of error and warning' chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9.
Product's decrease in sensitivity may result in false negative results
Complaints of prolonged clot times.