510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0441-2021Class III

Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

Hardy Diagnostics / initiated 2020-10-06 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Hardy Diagnostics began a recall of Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 on . FDA classified it as Class III and gives the reason as "Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of instead of the correct expiration date of ". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0441-2021
Classification
Class III
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hardy Diagnostics
Product
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Product code
PQZ Gbs Culture Media, Selective And Differential
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
Root cause tag
manufacturing process
FDA root cause
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 [email protected]. 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
Product codes and lots
Lot # 465086

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0441-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0441-2021Class IIITerminatedVoluntary: Firm initiated