Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton… — Class II medical device recall Z-1947-2025
Ongoing recall by Remel, Inc, reported 2025-06-18, distributed nationwide. Product may have an off color affecting perfomance
| Recall number | Z-1947-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel, Inc, Lenexa, KS, United States |
| Recall initiated | 2025-05-01 |
| Classified | 2025-06-11 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB |
| Quantity | 70 units |
| UPC / GTIN / UDI-DI | 00848838018855 |
| Lot numbers | 226414 |
| Model numbers | CP11410 |
Product
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Reason for recall
Product may have an off color affecting perfomance
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-1947-2025. 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.