PathoDx Strep Grouping Kit — Class II medical device recall Z-2350-2015
Terminated recall by Remel Inc, reported 2015-08-19, distributed nationwide. A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target
| Recall number | Z-2350-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2015-06-30 |
| Classified | 2015-08-07 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2017-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,859 kits |
| Lot numbers | 1470133 |
| Model numbers | 62025 |
| Expiration dates | 2016-03-31 |
Product
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
Reason for recall
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
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-2350-2015. 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.