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U.S. Department of Health and Human Services

Class 3 Device Recall Neonatal GALT Test Kit

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  Class 3 Device Recall Neonatal GALT Test Kit see related information
Date Initiated by Firm June 27, 2003
Date Posted August 20, 2003
Recall Status1 Terminated 3 on October 24, 2008
Recall Number Z-1139-03
Recall Event ID 26606
510(K)Number k950803  
Product Classification Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate - Product Code JLJ
Product Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
Code Information Lot #164738
Recalling Firm/
Manufacturer
PerkinElmer Life Sciences Inc
3985 Eastern Rd
Norton OH 44203
Manufacturer Reason
for Recall
The kits are producing lower values than expected, which may result in an increase of false positive test results.
FDA Determined
Cause 2
Other
Action The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.
Quantity in Commerce 85 kits
Distribution The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.
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 = JLJ and Original Applicant = ISOLAB, INC.
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