Recall Z-0441-2021 ยท PQZ Gbs Culture Media, Selective And Differential
Hardy Diagnostics
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
| Date | Oct 6, 2020 |
| Status | Terminated |
| 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170586 | Strep B Carrot Broth One-Step Hardy Diagnostics, May 22, 2017 |