FDA Enforcement
Class II
Terminated
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
Recall: Z-0919-2021
·
Reported February 3, 2021
Enforcement
- Recall Number
- Z-0919-2021
- Event ID
- 87091
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hardy Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 3, 2021
- Initiation Date
- December 21, 2020
- Classification Date
- January 25, 2021
- Termination Date
- September 28, 2022
- Address
- 1430 W McCoy Ln, Santa Maria, CA, 93455-1005, United States
Description
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
Reason
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Code Info
Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
Distribution
U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
Quantity
820 units (82 PK10)