FDA Medical Device Recalls (openFDA)
Hardy Diagnostics: Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
- Recall number
- Z-0441-2021
- Recalling firm
- Hardy Diagnostics
- Product
- Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
- Status
- Terminated
- Initiated
- 2020-10-06
- Posted
- not on file
- Terminated
- 2021-05-28
- Reason
- 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
- 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
- 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
- Lot, serial or model codes
- Lot # 465086
- 510(k) numbers
- K170586
- PMA numbers
- not on file
- Product code
- PQZ
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28