Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
Reported: May 4, 2016 Initiated: March 21, 2016 #Z-1571-2016
Product Description
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
Reason for Recall
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.
Details
- Recalling Firm
- Hardy Diagnostics
- Units Affected
- 3,530 (353 pk/10)
- Distribution
- U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
- Location
- Santa Maria, CA
Frequently Asked Questions
What product was recalled? ▼
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.. Recalled by Hardy Diagnostics. Units affected: 3,530 (353 pk/10).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1571-2016.
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