Reported May 4, 2016 · Terminated
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of…
Hardy Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hardy Diagnostics · 1430 W McCoy Ln · Santa Maria, CA · 93455-1005
Is this the product you have?
- Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
- Lot codes and dates
- Lot H16054 and H15056.
- Amount recalled
- 3,530 (353 pk/10)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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