FDA Device

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.

Hazard

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

What You Should Do

Remedy

On 4/28/2015, the recalling firm's European subsidiary notified the recalling firm of the recall. On 6/30/2015, the recalling firm notified their customers of the recall via letter, sent USPS standard mail.

Products

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 cultur
Brand
Remel Inc
UPC
lot 1470133, exp. date 31 Mar 2016

Units Affected

1859 kits