Date Initiated by Firm | December 21, 2020 |
Create Date | January 25, 2021 |
Recall Status1 |
Terminated 3 on September 28, 2022 |
Recall Number | Z-0919-2021 |
Recall Event ID |
87091 |
510(K)Number | K964560 |
Product Classification |
Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
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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 |
Code Information |
Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698 |
Recalling Firm/ Manufacturer |
Hardy Diagnostics 1430 W McCoy Ln Santa Maria CA 93455-1005
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For Additional Information Contact | Susan Pruett 805-346-2766 Ext. 5608 |
Manufacturer Reason for Recall | Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. |
FDA Determined Cause 2 | Under Investigation by 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 JohnsonL@HardyDiagnostics.com or by fax to (805)266-2222, option 2 or (805)361-5050 or via e-mail at TechnicalServices@HaryDiagnostics.com.
For any questions or further information contact Technical Services Department at 800-266-2222 ext. 5598 |
Quantity in Commerce | 820 units (82 PK10) |
Distribution | U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA
O.U.S. None |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JSO
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