Z-1571-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- March 21, 2016
- Termination Date
- October 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,530 (353 pk/10)
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.
Distribution Pattern
U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
Code Information
Lot H16054 and H15056.