FDA Medical Device Recalls (openFDA)
bioMerieux, Inc.: 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.
- Recall number
- Z-1534-2020
- Recalling firm
- bioMerieux, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2020-02-05
- Posted
- not on file
- Terminated
- 2022-10-28
- Reason
- The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
- Root cause
- Process control
- Action
- bioMerieux notified customers on about 02/05/2020 via "Urgent Product Correction Notice." The letter requested customers to check their inventory, destroy any recalled product, ensure the recall notice has been distributed to all appropriate personnel within your organization, and complete and return the attached Acknowledgement form.
- Quantity
- 4,130 kits (82,600 cards)
- Distribution
- International distribution in the countries of Germany and the Netherlands.
- Lot, serial or model codes
- REF: 422024 Lot Number: 0210932204
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28