Class 2 Device Recall

• Date Initiated by Firm: December 06, 2002
• Date Posted: January 30, 2003
• Recall Status: Terminated on July 26, 2003
• Recall Number: Z-0494-03
• Recall Event ID: 25392
• 510(K)Number: K955769
• Product Classification: Radioimmunoassay, Progesterone - Product Code JLS
• Product: Access Progesterone Assay, Part number 33550.
• Code Information: All Lots.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 South Kraemer Blvd W 337; Brea CA 92822
• For Additional Information Contact: Lynne McBride; 714-961-3626
• Manufacturer Reason for Recall: Primary tube sampling issue may cause false low results.
• FDA Determined Cause: Other
• Action: Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.
• Quantity in Commerce: 6,655
• Distribution: USA and Canada.
• 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 = JLS