Z-1197-2009

Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access...

Name: Z-1197-2009 Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access...
Creator: Beckman Coulter Inc
Published: 2008-01-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-01-08 / Terminated / root cause: packaging

FDA source

Beckman Coulter Inc began a recall of Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA assay is a paramagnetic particle... on 2008-01-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1197-2009
Status: Terminated
Initiated: 2008-01-08
Posted: 2009-04-28
Terminated: 2012-03-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Reason for recall: 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 tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 123 Units
Distribution: 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.
Product codes and lots: Lot Numbers: 715292 and 722462.

Product code LTJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)