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U.S. Department of Health and Human Services

Class 3 Device Recall Kallestad Mouse Stomach/Kidney (MSK) Test Kit

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  Class 3 Device Recall Kallestad Mouse Stomach/Kidney (MSK) Test Kit see related information
Date Initiated by Firm June 30, 2010
Date Posted August 22, 2011
Recall Status1 Terminated 3 on August 22, 2011
Recall Number Z-3051-2011
Recall Event ID 56251
510(K)Number K813592  
Product Classification Antinuclear Antibody, Indirect Immunofluorescent, Antigen - Product Code DHN
Product "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN"
The test kit contains slides and substrate.

For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.
Code Information MSK catalog number: 30443. Lot number: 101941. Slide Pack Lot number: 00100889006.
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact
425-498-1709
Manufacturer Reason
for Recall		 KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides.
FDA Determined
Cause 2		 Employee error
Action Bio-Rad Laboratories notified affected customers by phone on 6/30/2010 and followed up with a 2nd call on 7/13/2010. The call informed customers of the problem with the kit and requested they destroy the Crithidia slide packs. Bio-Rad send out replacement slide packs. For information or questions on this recall call Bio-Rad at (425) 498-1709.
Quantity in Commerce 224 kits were distributed; 35 of those kits were determined to contain the wrong slides.
Distribution Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico.
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 = DHN and Original Applicant = KALLESTAD LABORATORIES, INC.
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