Remel Blood Agar/MacConkey Agar Bi-Plate — Class II medical device recall Z-0769-2021
Terminated recall by Remel Inc, reported 2021-01-20, distributed in AL, FL, GA, LA, MS, NC, SC, TN. The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
| Recall number | Z-0769-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2020-12-10 |
| Classified | 2021-01-14 |
| Reported by FDA | 2021-01-20 |
| Terminated | 2023-07-06 |
| Distributed | AL, FL, GA, LA, MS, NC, SC, TN |
| Quantity | 637 units |
| Lot numbers | 150237 |
| Model numbers | R02049 |
Product
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Reason for recall
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
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-0769-2021. 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.