—#72531

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.

FDA product code: LTJ — Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Device class: Class 2
Medical specialty: Immunology
PMA numbers: P850048S016
Affected lot / code info: Lot Numbers: 715292 and 722462.

Why it was recalled

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.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-01-08
Posted by FDA: 2009-04-28
Terminated: 2012-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72531. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.