FDA Device recall Z-0562-2021
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry by Becton Dickinson And Bd Biosciences, citing recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0562-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-05 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
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
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Identifiers
| code_info | Lot Number: BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703…Lot Number: BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US 349705 00382903497058 US BD" Multi-Check CD4 Low Control Whole Blood Control for Lymphocyte Subset Enumeration OUS Distribution Catalog Number UDI 340914 00382903409143 OUS only 340915 00382903409150 OUS only 340916 00382903409167 OUS only |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0562-2021%22
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