Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
- Company
- Hardy Diagnostics
- Recall Initiated
- March 21, 2016
- Terminated
- October 25, 2016
- Recall Number
- Z-1571-2016
- Quantity
- 3,530 (353 pk/10)
- Firm Location
- Santa Maria, CA
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
U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
Lot / Code Info
Lot H16054 and H15056.
Root Cause
Under Investigation by firm
Action Taken
On 03/21/2016 customers were notified by phone, and were sent a notification letter. Customers were instructed via phone call to discard remaining plates of the implicated lot, and to notify the firm of how many plates are left. The firm stated that they will be issuing replacements. The firm stated that they will be sending written notification as well. The firm requested full name and e-mail or fax number in order to follow-up with the written notification. The customer notification letter instructs customers to complete, sign, scan/e-mail or fax back enclosed form stating compliance with the action regarding the specific lot. The firm requests the form be returned to the attention of the Quality Assurance Department at techservice@hardydiagnostics.com, fax number 805-614-9274. If the lab is unable to be reached via telephone and would like replacements or credit contact Customer Service Department at 800-266-2222, option 1. Replacements will be sent out at no charge. Any questions contact Technical Services Department at 800-266-2222, option 2 or via e-mail at techservice@hardydiagnostics.com.