FDA Device recall Z-1570-2016
BD Trucount Absolute Counting Tubes: Model number: 340334 IVD
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of BD Trucount Absolute Counting Tubes: Model number: 340334 IVD by Becton Dickinson And Bd Biosciences, citing one lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and present….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1570-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-31 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | CA, CO, CT, DE, FL, GA, LA, MD, MN, NC, NH, NY, OH, PA, TN, VA, WA |
Product
BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
Reason
One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.
Identifiers
| code_info | Model: 340334; Manufacaturing lot: 534964 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1570-2016%22
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