Device product
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
Z-2351-2015
Product summary
- Firm
- Remel Inc
- Event
- Event 71614
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4420 bottles
- Official record key
device-enforcement:Z-2351-2015
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 1463129, exp. date 31 May 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.