remel THIOGLYCOLLATE MEDIUM W/O INDICATOR — Class II medical device recall Z-3018-2018
Terminated recall by Remel Inc, reported 2018-09-19. Products have intermittently failed performance testing during stability studies with various anaerobic microo
| Recall number | Z-3018-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2018-08-13 |
| Classified | 2018-09-07 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2019-06-18 |
| Countries outside the US | CA, SG |
| Quantity | 384 units |
| Reason classes | specification failure |
| Lot numbers | 254751, 259508, 259521, 272498, 274247 |
| Model numbers | 064700, 064702, 07176 |
Product
remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
Reason for recall
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
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-3018-2018. 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.