remel THIOGLYCOLLATE MEDIUM W/O IND — Class II medical device recall Z-3017-2018
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-3017-2018 |
|---|---|
| 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 | 2,730 units |
| Reason classes | specification failure |
| Lot numbers | 251145, 251146, 254749, 254755, 258181, 258182, 258183, 258625, 258626, 258627, 258629, 258903, 258904, 258905, 258906, 258907, 258908, 259507, 259521, 259526, 260413, 260509, 260519, 271476, 271479, 271665, 271667, 272015, 272020, 272497, 272499, 273564 |
| Model numbers | 064720, 064730, 064732, 07180, 07182 |
Product
remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720
Reason for recall
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Machine access
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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.