remel TODD HEWITT W — Class II medical device recall Z-2531-2023
Ongoing recall by Remel, Inc, reported 2023-09-20, distributed nationwide. On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing
| Recall number | Z-2531-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel, Inc, Lenexa, KS, United States |
| Recall initiated | 2023-08-14 |
| Classified | 2023-09-08 |
| Reported by FDA | 2023-09-20 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00848838010064 |
| Lot numbers | 668255 |
| Model numbers | R064810 |
| Expiration dates | 2024-04-26 |
Product
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Reason for recall
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
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-2531-2023. 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.