remel RapID Yeast Plus System — Class II medical device recall Z-0530-2014
Terminated recall by Remel Inc, reported 2013-12-25, distributed nationwide. The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The lab
| Recall number | Z-0530-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2013-04-04 |
| Classified | 2013-12-17 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-03-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, JP |
| Quantity | 150 kits |
| Reason classes | microbial contamination, labeling |
| Pathogens | yeast |
| Lot numbers | 302532 |
| Model numbers | R8311007 |
| Expiration dates | 2014-02-06 |
Product
remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
Reason for recall
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
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-0530-2014. 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.