CLASS I Device recall · Reported 18 May 2016 · FDA Enforcement Report
Vitek Positive Susceptibility Test Cards (AST-P644 recalled
Biomerieux is recalling Vitek Positive Susceptibility Test Cards (AST-P644. The recall was initiated on 24 Feb 2016 and the FDA has classified it as Class I.
Check your package
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-1645-2016
- 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
- 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-P644 REF 418673), 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
Is Vitek Positive Susceptibility Test Cards (AST-P644 recalled?
Yes. Biomerieux recalled Vitek Positive Susceptibility Test Cards (AST-P644 on 24 Feb 2016. The recall is Class I and its status is Terminated. Recall number Z-1645-2016.
Why was it recalled?
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Which lots are affected?
Lots 744357740 exp. 9/29/16, 744383620 exp. 6/15/17, and 744389320 exp. 8/11/17.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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