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Recall Observatory FDA recall evidence

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

December 21, 2020

Class II

Product summary

Firm
Hardy Diagnostics
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

    reason.no_named_rule · v1.0.0

    Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.