—#72407

Product

Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.

FDA product code: MTG — Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P970038S004
Affected lot / code info: Part Number: 37215, Lot Number: 715293.

Why it was recalled

Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibration for free PSA is marketed without a PMA.

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter contacted customers by phone beginning January 11, 2009 and sending a Product Corrective Action letter informing them to discontinue use and discard the referenced product immediately. For further information, contact Customer Technical Support at 1-800-854-3633 or contact your local Beckman Coulter Representative.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.

Timeline

Recall initiated: 2008-01-08
Posted by FDA: 2009-09-16
Terminated: 2011-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72407. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.