FDA Device recall Z-0171-2016
BD CD3 (SK7) FITC
- FDA Device
- Class III
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class III recall of BD CD3 (SK7) FITC by Becton Dickinson And Bd Biosciences, citing two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0171-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-09-30 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | US |
Product
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
Reason
Two lots of CD3 (SK7) FITC label contains an error in the Spanish Small text.
Identifiers
| code_info | Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0171-2016%22
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