Class 3 Device Recall Neonatal GALT Test Kit

• Date Initiated by Firm: June 27, 2003
• Date Posted: August 20, 2003
• Recall Status: Terminated on October 24, 2008
• Recall Number: Z-1139-03
• Recall Event ID: 26606
• 510(K)Number: K950803
• Product Classification: Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate - Product Code JLJ
• Product: Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
• Code Information: Lot #164738
• Recalling Firm/ Manufacturer: PerkinElmer Life Sciences Inc; 3985 Eastern Rd; Norton OH 44203
• Manufacturer Reason for Recall: The kits are producing lower values than expected, which may result in an increase of false positive test results.
• FDA Determined Cause: Other
• Action: The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.
• Quantity in Commerce: 85 kits
• Distribution: The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.
• 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 = JLJ