Z-1401-2015Class III

Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use...

Name: Z-1401-2015 Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use...
Creator: Biomerieux Inc
Published: 2015-02-25
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2015-02-25 / Terminated / root cause: manufacturing process

FDA source

Biomerieux Inc began a recall of Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories... on 2015-02-25. FDA classified it as Class III and gives the reason as "The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use". 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-1401-2015
Classification: Class III
Status: Terminated
Initiated: 2015-02-25
Posted: 2015-04-08
Terminated: 2017-03-22
Recalling firm: bioMerieux, Inc.
Product: Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Product code: LTW Susceptibility Test Cards, Antimicrobial
Reason for recall: The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " For the referenced test kits (VITEK 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in the Package Insert antibiotic table to confirm which organisms can be tested. " Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae. " Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms. " Please store this letter with your bioMrieux instrument documentation. Please complete the attached Acknowledgement Form and return it to bioMrieux, Inc. Customers with questions were instructed to contact their local BioMerieux representative. For questions regarding this recall call 314-731-8526.
Quantity in commerce: 10409 cartons
Distribution: Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
Product codes and lots: lot 735352820, expiration 11AUG16; lot 735348620, expiration 30JUN16; lot 735346520, expiration 09JUN16; lot 735342320; expiration 28APR16; lot 735318020, expiration 29AUG15; lot 735315920, expiration 08AUG15; lot 735323710, expiration 25OCT15; lot 735310210, expiration 12JUN15

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1401-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1401-2015	Class III	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-08
Z-1402-2015	Class III	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-08
Z-1403-2015	Class III	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-08

Product code LTW

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)