FDA Device recall Z-2350-2015
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit
- FDA Device
- Class II
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit by Remel, citing A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2350-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-30 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Remel |
| Distribution | US |
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
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Identifiers
| code_info | lot 1470133, exp. date 31 Mar 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2350-2015%22
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