Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
- Company
- Hardy Diagnostics
- Recall Initiated
- December 21, 2020
- Terminated
- September 28, 2022
- Recall Number
- Z-0919-2021
- Quantity
- 820 units (82 PK10)
- Firm Location
- Santa Maria, CA
Reason for Recall
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Distribution
U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
Lot / Code Info
Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
Root Cause
Under Investigation by firm
Action Taken
On 12/21/2020, the firm sent an "URGENT: Medical Device Recall Notification" letter to customers via first class mail, email and/or facsimile informing them that seven customer complaints received of breakthrough of negative controls. Customers are instructed to: 1. Discard any remaining stock. The product should be destroyed according to local regulation as non-hazardous waste if un-inoculated, or as medical waste if inoculated. 2. Retain the Recall Notification and to notify any and all employees who may use the product. If the product was further distributed, to notify the consignees the product was distributed to. 3. Fill out the Product Recall Customer Inventory Form and to return the form within five (5) business days via e-mail to JohnsonL@HardyDiagnostics.com or by fax to (805)266-2222, option 2 or (805)361-5050 or via e-mail at TechnicalServices@HaryDiagnostics.com. For any questions or further information contact Technical Services Department at 800-266-2222 ext. 5598