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Recall Observatory FDA recall evidence

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

June 30, 2015

Class II

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

    reason.no_named_rule · v1.0.0

    A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.