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Terminated

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

FDA Recall Z-2233-2014 · Posted 2014-08-14

Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeGKZ
Date Initiated2014-07-18
Date Terminated2015-05-19
Product Quantity85

Reason for Recall

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

Firm Action

Global hold initiated on July 18, 2014. Customer letters sent by certified mail on July 18, 2014 to advised users of the problem.

Root Cause

Labeling mix-ups

Distribution Pattern

IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982231STATUSFLOWR&D Systems, Inc. · 1998-07-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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