Class 2 Device Recall Signify hCG Serum/Urine 30 Test Kit

• Date Initiated by Firm: May 05, 2006
• Date Posted: June 09, 2006
• Recall Status: Terminated on February 29, 2012
• Recall Number: Z-1100-06
• Recall Event ID: 35542
• Product Classification: Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
• Product: Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Lot# 84936, Exp 02/10/2007
• Code Information: Lot# 84936
• Recalling Firm/ Manufacturer: Applied Biotech Inc; 10237 Flanders Ct; San Diego CA 92121-2901
• For Additional Information Contact: Carmen Bergelin; 858-713-9640
• Manufacturer Reason for Recall: Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.
• FDA Determined Cause: Other
• Action: Distribution records indicate that the above product lot was produced for sale to Abbott Laboratories and Abbott Laboratories received all of the product lot. A recall certified recall letter was mailed 05/08/06. Abbott was also instructed if they have further distributed any of the referenced product lot, please see that their accounts are contacted, advise them of the urgent notification, and instruct them to destroy any of the affected product lot.
• Quantity in Commerce: 1198 Kits (35,940 Test)
• Distribution: In US : IL
• 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.