CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report
Vitek¿ 2 Compact recalled by Biomerieux
Biomerieux is recalling Vitek¿ 2 Compact 15. The recall was initiated on 12 Jul 2017 and the FDA has classified it as Class II.
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-3075-2017
- FDA event ID
- 77799
- Recalling firm
- Biomerieux, Hazelwood, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2017
- FDA classified
- 25 Aug 2017
- Reported
- 6 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Mold
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Jul 2017 | Recall initiated by company | |
| 25 Aug 2017 | Classified by FDA | +44 days |
| 6 Sep 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Product as listed by the FDA
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
Where it was distributed
Worldwide
Questions about this recall
Is Vitek¿ 2 Compact 15 recalled?
Yes. Biomerieux recalled Vitek¿ 2 Compact 15 on 12 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-3075-2017.
Why was it recalled?
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.
Which lots are affected?
VITEK¿ 2 Compact 15 and Compact 30 instruments previously manufactured/installed with VITEK¿ 2 System software versions prior to 5.01, and currently being upgraded to version 8.01.
Where was it sold?
Worldwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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|---|---|---|---|---|---|
| Device | CLASS II | Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux | Biomerieux | Other | Nationwide |
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