Strep B Carrot Broth One-Step — Class III medical device recall Z-0441-2021
Terminated recall by Hardy Diagnostics, reported 2020-11-18, distributed in AK, AL, AR, AZ, CA, CO, FL, GU…. Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling cont
| Recall number | Z-0441-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2020-10-06 |
| Classified | 2020-11-09 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2021-05-28 |
| Distributed | AK, AL, AR, AZ, CA, CO, FL, GU, ID, MI, MN, MO, MT, NC, NH, NY, PR, TX, VA, WA, WI, WY |
| Quantity | 8,620 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00819398026499 |
| Lot numbers | 465086 |
| Model numbers | Z40 |
Product
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0441-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.