Remel Xpect Clostridium difficile Toxin A/B — Class II medical device recall Z-0806-2013
Terminated recall by Remel Inc, reported 2013-02-20, distributed nationwide. The firm is recalling the products due to a potential for false negative test results.
| Recall number | Z-0806-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2012-08-20 |
| Classified | 2013-02-12 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB |
| Lot numbers | 082505, 131988, 131994 |
| Model numbers | 24650 |
Product
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.
Reason for recall
The firm is recalling the products due to a potential for false negative test results.
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-0806-2013. 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.