Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2016 - (Recall #: Z-1570-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 31, 2016

Date Posted: May 4, 2016

Recall Number: Z-1570-2016

Event ID: 73748

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.

Status: Terminated

Product Quantity: 1743; 467 US and 1276 International

Code Information:

Model: 340334; Manufacaturing lot: 534964

Distribution Pattern:

Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India.

Voluntary or Mandated:

Voluntary: Firm initiated