Class 2 Device Recall Architect Progesterone Reagent

• Date Initiated by Firm: March 31, 2003
• Date Posted: April 24, 2003
• Recall Status: Terminated on August 19, 2003
• Recall Number: Z-0782-03
• Recall Event ID: 25904
• Product Classification: Radioimmunoassay, Progesterone - Product Code JLS
• Product: Architect Progesterone Reagent Kit; list 6C26-27 (100 tests) and 6C26-22 (400 tests); Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
• Code Information: list 6C26-27, lot 95651M201 list 6C26-22, lots 95651M200, 95651M202
• Recalling Firm/ Manufacturer: Abbott Laboratories HPD/ADD; 100/200 Abbott Park Road; Abbott Park IL 60064
• For Additional Information Contact: Abbott Customer Support; 877-422-2688
• Manufacturer Reason for Recall: Lot gives lower specimen results compared to results generated with other lots.
• FDA Determined Cause: Other
• Action: Recalled by telephone calls and follow-up letters dated 3/31/03. The accounts were informed of the depressed patient specimen results, and were requested to discontinue use and destroy any of the three affected lots found in inventory. The accounts were advised to notify physicians of the lower patient results observed with these lots and suggest review of the patient results to determine any impact on patient management.
• Quantity in Commerce: 368 kits
• Distribution: Nationwide, Canada, Columbia, England, Japan, Australia, New Zealand and Singapore
• 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.