Device product
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
Z-0919-2021
Product summary
- Event
- Event 87091
- Status
- Terminated
- Classification
- Class II
- Quantity
- 820 units (82 PK10)
- Official record key
device-enforcement:Z-0919-2021
Official wording
Reason: Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Code information: Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
Distribution pattern: U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
Derived failure modes
-
Unknown
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.