Class 3 Device Recall GAO, Neonatal Total Galactose Test Kit

• Date Initiated by Firm: January 09, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-0514-04
• Recall Event ID: 28087
• 510(K)Number: k950481
• Product Classification: Enzymatic Methods, Galactose - Product Code JIA
• Product: Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000
• Code Information: Lots #177835, Exp 1/7/04; #178068, Exp 2/7/04; #195324, Exp 2/18/04; #204423, Exp 4/8/04; #207440, Exp 4/29/04; #213466, Exp 5/24/04.
• 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: Other
• Action: The firm contacted their customers by letter on 1/9/2004.
• Quantity in Commerce: 333 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.