BD" Mouse IgG2a Isotype Control APC X39 ASR — Class II medical device recall Z-2333-2021
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2021-09-01, distributed nationwide. Complaints have been received for performance issues related to high background and staining. this issues is r
| Recall number | Z-2333-2021 |
|---|---|
| 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 | 2021-07-22 |
| Classified | 2021-08-24 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2023-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | TW |
| Quantity | 23 reagents |
| UPC / GTIN / UDI-DI | 00382903407576 |
| Lot numbers | 0253432 |
| Model numbers | 340757 |
Product
BD" Mouse IgG2a Isotype Control APC X39 ASR
Reason for recall
Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.
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-2333-2021. 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.