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FDAMarch 21, 2016device

Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.

What to do

FDA enforcement status: Terminated

Brands named

hardy diagnosticshardy

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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