Recall Z-2233-2014— BD Biosciences, Systems & Reagents

Name: FDA recall Z-2233-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-18

Class III · Terminated

Class III FDA medical device recall by BD Biosciences, Systems & Reagents, initiated 2014-07-18, terminated 2015-05-19. It names one FDA 510(k) clearance: K982231. Product: BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.. Reason: The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02.

Recalling firm: BD Biosciences, Systems & Reagents
Classification: Class III
Status: Terminated
Initiated: 2014-07-18
Terminated: 2015-05-19
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K982231 — STATUSFLOWR&D Systems, Inc.·cleared 1998-07-20

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 Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

Reason for recall

The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02

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