Z-2220-2009

Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a...

Name: Z-2220-2009 Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a...
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: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay... on 2008-01-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2220-2009
Status: Terminated
Initiated: 2008-01-08
Posted: 2009-09-16
Terminated: 2011-11-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
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.
Root cause tag: manufacturing process
FDA root cause: Other
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.
Quantity in commerce: 22 Kits
Distribution: Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.
Product codes and lots: Part Number: 37215, Lot Number: 715293.

Product code MTG

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)