FDAFDA · Food and drugs·Recall number Z-2350-2015
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.
Published August 19, 2015 · Recall initiated: June 30, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Inc
- Distributor
- Nationwide Distribution, including Puerto Rico and the country of Canada.
- Lot
- lot 1470133, exp. date 31 Mar 2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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