CLASS I Device recall · Reported 18 May 2016 · FDA Enforcement Report

Vitek Positive Susceptibility Test Cards (AST-P643 recalled

Biomerieux is recalling Vitek Positive Susceptibility Test Cards (AST-P643. The recall was initiated on 24 Feb 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLots 743357720 exp. 9/29/16, 743366820 exp. 12/29/16, 743376510 exp. 4/5/17, 743380820 exp. 5/18/17, and 743387820 exp. 7/27/17.

Quantity recalled2,570 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1644-2016
FDA event ID: 73413
Recalling firm: Biomerieux, Hazelwood, MO
Classification: Class I
Status: Terminated
Recall initiated: 24 Feb 2016
FDA classified: 11 May 2016
Reported: 18 May 2016
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

24 Feb 2016	Recall initiated by company
11 May 2016	Classified by FDA	+77 days
18 May 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 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.

Where it was distributed

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

Questions about this recall

Why was it recalled?

Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Which lots are affected?

Lots 743357720 exp. 9/29/16, 743366820 exp. 12/29/16, 743376510 exp. 4/5/17, 743380820 exp. 5/18/17, and 743387820 exp. 7/27/17.

Where was it sold?

Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 73413

This product is part of a recall event; the main page for the event is Vitek Positive Susceptibility Test Cards (AST-P640 recalled.

Reported	Class	Recall	Company	Reason	Where
18 May 2016	CLASS I	Vitek Positive Susceptibility Test Cards (AST-P640 recalled	Biomerieux	Device Malfunction	MO
18 May 2016	CLASS I	Vitek Positive Susceptibility Test Cards (AST-P645 recalled	Biomerieux	Device Malfunction	MO
18 May 2016	CLASS I	Vitek Positive Susceptibility Test Cards (AST-P639 recalled	Biomerieux	Device Malfunction	MO
18 May 2016	CLASS I	Vitek Positive Susceptibility Test Cards (AST-P644 recalled	Biomerieux	Device Malfunction	MO
18 May 2016	CLASS I	Vitek Positive Susceptibility Test Cards (AST-P642 recalled	Biomerieux	Device Malfunction	MO
18 May 2016	CLASS I	Vitek Positive Susceptibility Test Cards (AST-P646 recalled	Biomerieux	Device Malfunction	MO
18 May 2016	CLASS I	Vitek Positive Susceptibility Test Cards (AST-P636 recalled	Biomerieux	Device Malfunction	MO
18 May 2016	CLASS I	Vitek Positive Susceptibility Test Cards (AST-P641 recalled	Biomerieux	Device Malfunction	MO

More recalls from Biomerieux

All 476

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	MO
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Sterility	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Sterility	NC
1 May 2024Device	CLASS I	Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled	Biomerieux	Other	MO
8 Mar 2023Device	CLASS II	Myla comprises Ast Filters in conjunction with Vitek MS recalled	Biomerieux	Other	Nationwide

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All 2,656

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