Remel Inc recalls PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-h…

Recall date

June 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2350-2015

FDA classification

Class II

Brand / firm

Remel Inc

Sold / distributed

Nationwide Distribution, including Puerto Rico and the country of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.