BD Trucount Absolute Counting Tubes: Model number: 340334 IVD — Class II medical device recall Z-1570-2016

Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2016-05-04, distributed in CA, CO, CT, DE, FL, GA, LA, MD…. One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead cou

Recall number	`Z-1570-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States
Recall initiated	2016-03-31
Classified	2016-04-26
Reported by FDA	2016-05-04
Terminated	2017-05-26
Distributed	CA, CO, CT, DE, FL, GA, LA, MD, MN, NC, NH, NY, OH, PA, TN, VA, WA
Countries outside the US	CN, IN, JP
Lot numbers	`534964`
Model numbers	`340334`, `340334IVD`

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1570-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.