Class 3 Device Recall Neonatal Total Galactose Test Kit

• Date Initiated by Firm: May 30, 2003
• Date Posted: July 02, 2003
• Recall Status: Terminated on October 24, 2008
• Recall Number: Z-0971-03
• Recall Event ID: 26412
• 510(K)Number: K950481
• Product Classification: Enzymatic Methods, Galactose - Product Code JIA
• Product: Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.
• Code Information: Lot #116020, Exp 7/4/03.
• Recalling Firm/ Manufacturer: PerkinElmer Life Sciences Inc; 3985 Eastern Rd; Norton OH 44203
• 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 telephone and facsimile on 5/30/2003.
• Quantity in Commerce: 42 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