FDA recall Z-0919-2021

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

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

Key facts

Status

Terminated

Initiation date

2020-12-21

Report date

2021-02-03

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0919-2021