Analyte specific reagent — Class II medical device recall Z-1971-2020
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2020-05-20, distributed nationwide. False positive reaction on the reagent.
| Recall number | Z-1971-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2020-03-31 |
| Classified | 2020-05-13 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CN, HK, IN, JP, KR, MY, NZ, SG, TW, VN |
| Quantity | 1,473 vials |
| Lot numbers | 541417/9056804, 641399/9065949, 641408/9057729 |
Product
Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis.
Reason for recall
False positive reaction on the reagent.
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-1971-2020. 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.