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U.S. Department of Health and Human Services

Class 2 Device Recall ATAC Serum Control Kit

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  Class 2 Device Recall ATAC Serum Control Kit see related information
Date Initiated by Firm December 04, 2009
Date Posted April 06, 2010
Recall Status1 Terminated 3 on July 25, 2012
Recall Number Z-1234-2010
Recall Event ID 54279
510(K)Number K040273  
Product Classification Multi-Analyte Controls, All Kinds (Assayed) - Product Code JJY
Product ATAC Serum Control Kit.

The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
Code Information Level 1, Lot Number 9137010 and Level 2, Lot Number 9138010.
Recalling Firm/
Manufacturer		 Vital Diagnostics, Inc.
27 Wellington Rd
Lincoln RI 02865-4411
For Additional Information Contact
401-642-8400
Manufacturer Reason
for Recall		 Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.
FDA Determined
Cause 2		 Other
Action Customers were mailed copies of Technical Bulletin 8100 and 5024 dated September 30, 2009 which advised of the Alkaline Phosphatase QC value revisions for the Envoy 500 and the ATAC 8000. If you have any questions, please contact Vital Diagnostics Technical Support at 1-800-345-2822.
Quantity in Commerce 802 Kits
Distribution Nationwide.
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 = JJY and Original Applicant = BIO-RAD LABORATORIES, INC.
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