Food, drugs, devices › bioMerieux, Inc.
Device recall: VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reage
bioMerieux, Inc. (Durham, NC) initiated this device recall on 5 Feb 2020; FDA lists 1 product record under event 84993, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 28 Oct 2022. Initiation: voluntary: firm initiated. bioMerieux, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
bioMerieux, Inc., Durham, NC.
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
"International distribution in the countries of Germany and the Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1534-2020 | 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… | 4,130 kits (82,600 cards) | Class II | Terminated | 1 Apr 2020 |
Context
Other enforcement events for bioMerieux, Inc.
All 57 events for bioMerieux, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "International distribution in the countries of Germany and the Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Oct 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.