Device 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.
Z-2350-2015
Product summary
- Firm
- Remel Inc
- Event
- Event 71614
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1859 kits
- Official record key
device-enforcement:Z-2350-2015
Official wording
Reason: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Code information: lot 1470133, exp. date 31 Mar 2016
Distribution pattern: Nationwide Distribution, including Puerto Rico and the country of Canada.
Derived failure modes
-
Unknown
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.