Z-1534-2020Class II

VITEK 2 card AST-N371 -

Name: Z-1534-2020 VITEK 2 card AST-N371 -
Creator: bioMerieux, Inc.
Published: 2020-02-05
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2020-02-05 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the... on 2020-02-05. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1534-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-05
Posted: 2020-03-20
Terminated: 2022-10-28
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.
Product code: N/A
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 4,130 kits (82,600 cards)
Distribution: International distribution in the countries of Germany and the Netherlands.
Product codes and lots: REF: 422024 Lot Number: 0210932204

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1534-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1534-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)