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U.S. Department of Health and Human Services

Class 3 Device Recall Neonatal Total Galactose Test Kit

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  Class 3 Device Recall Neonatal Total Galactose Test Kit see related information
Date Initiated by Firm May 30, 2003
Date Posted July 02, 2003
Recall Status1 Terminated 3 on October 24, 2008
Recall Number Z-0969-03
Recall Event ID 26412
510(K)Number k950481  
Product Classification Enzymatic Methods, Galactose - Product Code JIA
Product Neonatal Total Galactose Test Kit, Item #NG-1000, Filter #903, contents for 960 assays.
Code Information Lots: #112770, Exp 6/14/03; and #116017, Exp 7/4/03.
Recalling Firm/
PerkinElmer Life Sciences Inc
3985 Eastern Rd
Norton OH 44203
For Additional Information Contact
Manufacturer Reason
for Recall
The device is not stable throughout its labeled expiration date.
FDA Determined
Cause 2
Action The firm contacted their customers by telephone and facsimile on 5/30/2003.
Quantity in Commerce 100 kits
Distribution Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea.
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 = JIA and Original Applicant = ISOLAB, INC.