Recall Z-2252-2016— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-2252-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-24

Class II · Terminated

Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2016-06-24, terminated 2016-12-02. It names one FDA 510(k) clearance: K970836. Product: BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.. Reason: 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..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class II
Status: Terminated
Initiated: 2016-06-24
Terminated: 2016-12-02
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 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.

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