Recall Z-0173-2023— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-0173-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-03

Class II · Ongoing

Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2022-10-03. It names one FDA 510(k) clearance: K090967. Product: BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.. Reason: Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class II
Status: Ongoing
Initiated: 2022-10-03
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K090967 — BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611Bd Biosciences·cleared 2009-07-31

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 Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.

Reason for recall

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

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