Z-1646-2016Class I

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit

Name: Z-1646-2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit
Creator: Biomerieux Inc
Published: 2016-02-24
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2016-02-24 / Terminated / root cause: labeling and UDI

FDA source

Biomerieux Inc began a recall of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended... on 2016-02-24. FDA classified it as Class I and gives the reason as "Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1646-2016
Classification: Class I
Status: Terminated
Initiated: 2016-02-24
Posted: 2016-05-11
Terminated: 2018-03-08
Recalling firm: bioMerieux, Inc.
Product: Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Product code: LTW Susceptibility Test Cards, Antimicrobial
Reason for recall: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioMrieux representative.
Quantity in commerce: 1,524 kits
Distribution: Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
Product codes and lots: Lots 745363420 exp. 11/25/16 and 745375920 exp. 3/30/17.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1646-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1639-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1640-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1641-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1642-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1643-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1644-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1645-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1646-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11
Z-1647-2016	Class I	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)