VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) A
FDA device recall Z-1464-2024 · posted 2024-04-25 · Open, Classified
Recall details
- Recalling firm
- Biomerieux Inc
- Reason for recall
- Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
- Action taken
- BioMerieux issued an URGENT FIELD SAFETY NOTICE to its consignees on 03/14/2024 via email. The notice explained the issue, impact to patient, and provided the consignee (user) with alternate testing methods. BioMerieux issued another URGENT FIELD SAFETY NOTICE dated 07MAY2024 to its consignees on May 9, 2024, via email. This letter includes the statement, "however, no results for the Ceftriaxone (cro02n) should be reported outside the lab."
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- LON
- Quantity affected
- 49215 units
- Distribution
- Worldwide
- Date initiated
- 2024-03-14
- Date posted
- 2024-04-25
- Location
- Hazelwood, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) (K161217) | bioMerieux, Inc. | 2017-01-12 |