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U.S. Department of Health and Human Services

Class 2 Device Recall Perkin Elmer

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  Class 2 Device Recall Perkin Elmer see related information
Date Initiated by Firm March 11, 2005
Date Posted June 09, 2005
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0879-05
Recall Event ID 31703
510(K)Number K031878  
Product Classification System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry - Product Code NQL
Product Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit
Code Information Catalog Number: MS-8970 Lot numbers: 252208, 257031, 258928, 258937, 259588, 263097, 267166 , 267628, 268256, 268258, 268403, 268404, 268675  
Recalling Firm/
Manufacturer		 Perkin Elmer Life And Analytical
331 Treble Cove Rd
North Billerica MA 01862-2849
Manufacturer Reason
for Recall		 Pump failure may effect data integrity
FDA Determined
Cause 2		 Other
Action Perkin Elmer notified US Customers by letter on 3/11/05. Instructions were provided to service engineers for preventative maintenance. During the week of 5/5/05, the firm is issuing a recall letter recalling the solvents and solutions of these kits. The firm will send a Service Engineer to oversee destruction and maintenance of the pump.
Quantity in Commerce 622 kits
Distribution AL, CA, CT, FL, IN, LA, GA, MI, MO, NJ, OR,SC
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.
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