Class 2 Device Recall Access Immunoassay Systems Hybritech PSA Calibrator

• Date Initiated by Firm: January 08, 2008
• Date Posted: April 28, 2009
• Recall Status: Terminated on March 15, 2012
• Recall Number: Z-1197-2009
• Recall Event ID: 49019
• PMA Number: P850048S016
• Product Classification: Prostate-specific antigen (PSA) for management of prostate cancers - Product Code LTJ
• Product: Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.
• Code Information: Lot Numbers: 715292 and 722462.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 S Kraemer Blvd; Brea CA 92822-6208
• For Additional Information Contact: 714-993-5321 Ext. 8383
• Manufacturer Reason for Recall: Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.
• FDA Determined Cause: Packaging process control
• Action: An "Urgent: Product Corrective Action" letter dated January 10, 2008 was issued via fax or mail to customers. The letter described the issue and instructed consignees to discontinue use and discard the affected product. Consignees were also asked to complete and return a "Fax-Back Form" via fax (1-952-368-7610) or mail to Beckman Coulter, Inc. within 10 days of receiving the notification letter. Further questions should be addressed to Beckman Coulter Customer Technical Support at 1-800-854-3633.
• Quantity in Commerce: 123 Units
• Distribution: Nationwide Distribution -- Including states of AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OK, OR, PA, SC, TN, TX, VA, WI and WV.
• 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.

• PMA Database: PMAs with Product Code = LTJ