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Terminated

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 Recall Z-2220-2009 · Posted 2009-09-16

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeMTG
Date Initiated2008-01-08
Date Terminated2011-11-29
Product Quantity22 Kits

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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