Data Foundry

Medical device recalls 2016

BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount… — Class II medical device recall Z-2252-2016

Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2016-07-27, distributed in AR, AZ, CA, IN, KY, MA, MD, NC…. One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient enviro

Recall numberZ-2252-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton, Dickinson and Company, BD Biosciences, San Jose, CA, United States
Recall initiated2016-06-24
Classified2016-07-21
Reported by FDA2016-07-27
Terminated2016-12-02
DistributedAR, AZ, CA, IN, KY, MA, MD, NC, NJ, NY, OH, PA, PR, SD, VA, WA, WI
Countries outside the USBE, CA, CL
Lot numbers6083708
Model numbers340334

Product

BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.

Reason for recall

One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

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-2252-2016. 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.