FDAJune 30, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
What to do
FDA enforcement status: Terminated
Brands named
remel
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOxoid Agglutinating Sera, Salmonella 9-0 R309573012026-03-25
- FDAYeastone Broth, 11ML, 10/BOX YY34622026-03-24
- FDACampy CVA Medium 100/PK, R012722026-02-05
- FDA1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT34502025-11-12
- FDABlood Agar,5% Sheep Blood 100/PK, Product Number R012022025-07-11
- FDAStrep Selective II Agar, Product Number R018592025-07-11
- FDABlood/MacConkey Biplate 100/PK, Product Number R020492025-07-11
- FDABlood/EMB, Levine 100/PK, Product Number R020412025-07-11
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