Cell Marque — Class II medical device recall Z-2105-2021
Terminated recall by Cell Marque Corporation, reported 2021-07-28, distributed in AL, AR, AZ, CA, FL, HI, ID, IL…. Product distributed for use as an In-vitro Diagnostics without FDA clearance
| Recall number | Z-2105-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cell Marque Corporation, Rocklin, CA, United States |
| Recall initiated | 2021-05-27 |
| Classified | 2021-07-21 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2024-04-05 |
| Distributed | AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI |
| Quantity | 41 kits |
| UPC / GTIN / UDI-DI | 00841683123798 |
| Lot numbers | 0000058081, 0000072580, 0000090505, 0000121052 |
| Model numbers | 117R-18 |
| Expiration dates | 2021-09-30, 2021-12-31, 2022-09-30, 2023-05-31 |
Product
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Reason for recall
Product distributed for use as an In-vitro Diagnostics without FDA clearance
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-2105-2021. 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.