Beckman Coulter Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Part Number: 37215, Lot Number: 715293.
Products Sold
Part Number: 37215, Lot Number: 715293.
Beckman Coulter Inc is recalling Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA ass due to Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026