Streptex* kit — Class II medical device recall Z-0537-2014
Terminated recall by Remel Inc, reported 2013-12-25, distributed nationwide. The product may give weak or false negative test results.
| Recall number | Z-0537-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2013-05-02 |
| Classified | 2013-12-18 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 768 kits |
| Lot numbers | 1192181 |
| Model numbers | R30950501, ZL50 |
| Expiration dates | 2014-01-20 |
Product
Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.
Reason for recall
The product may give weak or 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-0537-2014. 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.