Beckman Coulter Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lot Numbers: 715292 and 722462.
Products Sold
Lot Numbers: 715292 and 722462.
Beckman Coulter Inc is recalling Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Acc due to Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PS. 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 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.
Recommended Action
Per FDA guidance
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.
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