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U.S. Department of Health and Human Services

Class 2 Device Recall Neonatal GALT Test Kit

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  Class 2 Device Recall Neonatal GALT Test Kit see related information
Date Initiated by Firm January 08, 2003
Date Posted May 29, 2003
Recall Status1 Terminated 3 on September 13, 2008
Recall Number Z-0898-03
Recall Event ID 26138
510(K)Number K950803  
Product Classification Enzyme Controls (Assayed And Unassayed) - Product Code JJT
Product Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
Code Information Lot #115496, Exp. 11/1/03
Recalling Firm/
PerkinElmer LIfe Sciences Inc
3985 Eastern Rd
Norton OH 44203
Manufacturer Reason
for Recall
The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
FDA Determined
Cause 2
Action The firm notified their customers by letter on 1/8/2003.
Quantity in Commerce 75 Kits
Distribution The kits were shipped to three (3) State Departments of Health in WI, AR, and MI.
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 = JJT and Original Applicant = ISOLAB, INC.