Z-1534-2020 Class II Terminated
FDA device recall Z-1534-2020 was initiated by bioMerieux, Inc. on February 5, 2020 and is designated Class II. Reason for recall: The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card. The recall status is terminated (terminated October 28, 2022). Affected quantity: 4,130 kits (82,600 cards).
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 5, 2020
- Termination Date
- October 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,130 kits (82,600 cards)
Product Description
VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.
Reason for Recall
The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
Distribution Pattern
International distribution in the countries of Germany and the Netherlands.
Code Information
REF: 422024 Lot Number: 0210932204