Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card — Class III medical device recall Z-1401-2015
Terminated recall by Biomerieux Inc, reported 2015-04-15. The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae
| Recall number | Z-1401-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2015-02-25 |
| Classified | 2015-04-08 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2017-03-22 |
| Countries outside the US | GB, TR |
| Quantity | 10,409 cartons |
| Reason classes | labeling |
| Lot numbers | 735310210, 735315920, 735318020, 735323710, 735342320, 735346520, 735348620, 735352820 |
| Model numbers | 416, 911 |
| Expiration dates | 2015-06-12, 2015-08-08, 2015-08-29, 2015-10-25, 2016-04-28, 2016-06-09, 2016-06-30, 2016-08-11 |
Product
Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Reason for recall
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1401-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.