Recall Z-1570-2016— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-1570-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-31

Class II · Terminated

Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2016-03-31, terminated 2017-05-26. It names one FDA 510(k) clearance: K970836. 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..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Terminated: 2017-05-26
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K970836 — TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADSBecton Dickinson Immunocytometry Systems·cleared 1997-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.