FDA Device recall Z-2333-2021
BD" Mouse IgG2a Isotype Control APC X39 ASR
- FDA Device
- Class II
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of BD" Mouse IgG2a Isotype Control APC X39 ASR by Becton Dickinson And Bd Biosciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2333-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-22 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
Product
BD" Mouse IgG2a Isotype Control APC X39 ASR
Reason
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.
Identifiers
| code_info | Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2333-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.