Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hardy Diagnostics GBS Detect Cat no. A300. Used for the Recalled by Hardy Diagnostics Due to Performance failure; poor hemolytic reaction of non or...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hardy Diagnostics directly.
Affected Products
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
Quantity: 3,530 (353 pk/10)
Why Was This 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.
Where Was This Sold?
This product was distributed to 14 states: AL, CT, FL, IL, IN, MA, MI, NC, OH, SC, TX, VA, WV, WI
About Hardy Diagnostics
Hardy Diagnostics has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report