FDA Device recall Z-0171-2023
BD Trucount Tubes (Cat
- FDA Device
- Class II
- ongoing
- Published 2022-11-09
On 2022-11-09 the FDA classified a Class II recall of BD Trucount Tubes (Cat by Becton Dickinson And Bd Biosciences, citing due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash as….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0171-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-03 |
| Published | 2022-11-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI |
Product
BD Trucount Tubes (Cat. No. 340334), 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
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.
Identifiers
| code_info | Added/Corrected as of 11/04/2022: Catalog Number: 340334 UDI-DI Code: 00382903403349 Lot Numbers: 2031144 2034642 20351…Added/Corrected as of 11/04/2022: Catalog Number: 340334 UDI-DI Code: 00382903403349 Lot Numbers: 2031144 2034642 2035110 2035121 2060660 2073297 2073298 2095186 2101458 2108676 2112862 2152055 2152064 2152068 2152075 2152080 2203024 2208091 2215812 2235269 2223229 2236782 2236934 2236936 2236937 2236783 2237006 2237008 2237012 2237014 2237015 2237016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0171-2023%22
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