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
FDA Recall Z-0919-2021 · Posted None
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Recalling FirmHardy Diagnostics
Recall StatusTerminated
Product CodeJSO
Date Initiated2020-12-21
Date Terminated2022-09-28
Product Quantity820 units (82 PK10)
Reason for Recall
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Firm Action
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 [email protected] or by fax to (805)266-2222, option 2 or (805)361-5050 or via e-mail at [email protected].
For any questions or further information contact Technical Services Department at 800-266-2222 ext. 5598
Root Cause
Under Investigation by firm
Distribution Pattern
U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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