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U.S. Department of Health and Human Services

Class 2 Device Recall Hardy Diagnostics Brain Heart Infusion Agar (BHIA) with 6 ug/ml of vancomycin

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  Class 2 Device Recall Hardy Diagnostics Brain Heart Infusion Agar (BHIA) with 6 ug/ml of vancomycin see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = JSO and Original Applicant = HARDY DIAGNOSTICS
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