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U.S. Department of Health and Human Services

Class 2 Device Recall Neonatal Total Galactose Test Kit.

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  Class 2 Device Recall Neonatal Total Galactose Test Kit. see related information
Date Initiated by Firm September 08, 2004
Date Posted September 30, 2004
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-1499-04
Recall Event ID 29979
Product Classification Enzymatic Methods, Galactose - Product Code JIA
Product Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
Code Information Lot #244468
Recalling Firm/
Manufacturer		 PerkinElmer LAS Inc
3985 Eastern Rd
Norton OH 44203-6215
For Additional Information Contact Cindy Lloyd
800-321-9632
Manufacturer Reason
for Recall		 There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.
FDA Determined
Cause 2		 Other
Action The firm contacted their consignees by letter sent 9/8/04.
Quantity in Commerce 49 kits
Distribution The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.
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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