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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.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
There are 7 reported software anomalies that may affect use of the device.
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
Invalid calibrations (out of range high) while using the product.
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
There is potential to provide an incorrect organism identification.
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.