Oxoid Nitrocefin — Class II medical device recall Z-1921-2016
Terminated recall by Remel Inc, reported 2016-06-15. Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false ne
| Recall number | Z-1921-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2016-03-24 |
| Classified | 2016-06-07 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-02-13 |
| Quantity | 2 units |
| Lot numbers | 1717357, SR0112C |
| Model numbers | SR0112C |
| Expiration dates | 2017-08-31 |
Product
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
Reason for recall
Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
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-1921-2016. 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.