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U.S. Department of Health and Human Services

Class 3 Device Recall Strep B Carrot Broth" OneStep

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  Class 3 Device Recall Strep B Carrot Broth" OneStep see related information
Date Initiated by Firm October 06, 2020
Create Date November 10, 2020
Recall Status1 Terminated 3 on May 28, 2021
Recall Number Z-0441-2021
Recall Event ID 86586
510(K)Number K170586  
Product Classification GBS culture media, selective and differential - Product Code PQZ
Product Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Code Information Lot # 465086
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W McCoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact Hardy Diagnostic Technical Services
800-266-2222 Ext. 2
Manufacturer Reason
for Recall		 Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10
FDA Determined
Cause 2		 Employee error
Action Hardy Diagnostic sent a "Urgent: Recall Notification" on 9/30/2020 and sent a follow-up letter 10/06/2020 containing additional information. In addition to notifying consignees about the recall, the firm asked consignees to take the following actions: 1. Please respond to the notification within 10 business days of receipt of the letter, either through mail or email. 2. To respond by email, please scan and send the completed inventory reconciliation form (FORM-2023C) to TechService@HardyDiagnostics.com. After a response is received, new labels with the correct expiration date will be sent to you for product that has not yet been used. 3. Upon expiration of the product, on November 10, 2020, discard any remaining stock. This product should be destroyed according to local regulation as non-hazardous waste if un-inoculated or as medical waste if inoculated. 4. Please retain this letter or post the letter where the product is stored to ensure the users are aware of this defect. Additionally, please take the following actions: - Notify any and all employees who may use the product. - If the product was further distributed, notify the consignees the product was distributed to. 5. Any Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online (www.fda.gov/medwatch/report.htm), by regular mail or by fax. 6. Please feel free to contact Technical Services if you have additional questions about this notification through email (listed above) or through phone call at (800) 266-2222, option 2, Monday through Friday, 8:00 AM to 5:00 PM, Pacific Time.
Quantity in Commerce 8,620 units
Distribution US: VA, AR, WI, ID, NY, AL, CA, MT, TX, MN, NH, WA, NC, NY, AZ, AK, MO, FL, MI, WY, ID, CO, AL, MT, WY, Puerto Rico, and Guam
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 = PQZ and Original Applicant = Hardy Diagnostics
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