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U.S. Department of Health and Human Services

Class 3 Device Recall GAO, Neonatal Total Galactose Test Kit

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  Class 3 Device Recall GAO, Neonatal Total Galactose Test Kit see related information
Date Initiated by Firm January 09, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-0515-04
Recall Event ID 28087
510(K)Number k950481  
Product Classification Enzymatic Methods, Galactose - Product Code JIA
Product Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
Code Information Lots #178052, Exp 2/7/04; #182567, Exp 1/7/04; #195339, Exp 2/18/04; #207487, Exp 4/29/04.
Recalling Firm/
Manufacturer
Perkin Elmer Life and Analytical Sciences Inc
3985 Eastern Rd
Norton OH 44203-6215
For Additional Information Contact
330-825-4525
Manufacturer Reason
for Recall
The device is not stable throughout its labeled expiration date.
FDA Determined
Cause 2
Other
Action The firm contacted their customers by letter on 1/9/2004.
Quantity in Commerce 178 kits
Distribution The kits were shipped to domestic end-users located in NJ, PA, TX, IN, MI, MO, IL, CO, CT, AR, FL, LA, OH, NM, WA.
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.
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