Date Initiated by Firm |
July 18, 2014 |
Date Posted |
August 14, 2014 |
Recall Status1 |
Terminated 3 on May 19, 2015 |
Recall Number |
Z-2233-2014 |
Recall Event ID |
68892 |
510(K)Number |
K982231
|
Product Classification |
Counter, differential cell - Product Code GKZ
|
Product |
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
|
Code Information |
Catalog number 340916; Lot number BM084L |
Recalling Firm/ Manufacturer |
BD Biosciences, Systems & Reagents 2350 Qume Dr San Jose CA 95131-1812
|
For Additional Information Contact |
Eric Claussen 408-954-6348
|
Manufacturer Reason for Recall |
The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Global hold initiated on July 18, 2014. Customer letters sent by certified mail on July 18, 2014 to advised users of the problem. |
Quantity in Commerce |
85 |
Distribution |
IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GKZ and Original Applicant = R & D SYSTEMS, INC.
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