BD" Multi-Check CD4 Low Control 2 — Class II medical device recall Z-0562-2021
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2020-12-16, distributed nationwide. Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result
| Recall number | Z-0562-2021 |
|---|---|
| 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 | 2020-10-05 |
| Classified | 2020-12-10 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2022-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CR, EC, IN, JP, KR, PE, PK, SG, TH, VN |
| Quantity | 619 vials |
| UPC / GTIN / UDI-DI | 00382903409143, 00382903409150, 00382903409167, 00382903497034, 00382903497041, 00382903497058 |
| Lot numbers | BM1020LBD, CD4 |
| Model numbers | 00382903409143OUS, 00382903497034US, 00382903497041US, 00382903497058US, 340914, 349703, 349704, 349705, CD4 |
Product
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Reason for recall
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
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-0562-2021. 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.