FDA Device recall Z-0441-2021
Strep B Carrot Broth One-Step, Ref
- FDA Device
- Class III
- terminated
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class III recall of Strep B Carrot Broth One-Step, Ref by Hardy Diagnostics, citing 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 expirati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0441-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-10-06 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hardy Diagnostics |
| Distribution | AK, AL, AR, AZ, CA, CO, FL, ID, MI, MN, MO, MT, NC, NH, NY, PR, TX, VA, WA, WI, WY |
Product
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
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
Identifiers
| code_info | Lot # 465086 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2021%22
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