Z-1645-2012

Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate...

Name: Z-1645-2012 Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate...
Creator: Beckman Coulter Inc.
Published: 2011-10-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-10-11 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total... on 2011-10-11. The reason FDA records is "A recall was initiated because Beckman Coulter has confirmed a change to the recommended diluents for the Access Hybritech free PSA reagent". 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-1645-2012
Status: Terminated
Initiated: 2011-10-11
Posted: 2012-05-22
Terminated: 2013-03-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL.
Product code: MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Reason for recall: A recall was initiated because Beckman Coulter has confirmed a change to the recommended diluents for the Access Hybritech free PSA reagent.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed regarding a change to the recommended diluents for the Access Hybritech free PSA reagent. Patient safety is not affected by this change. " Do not dilute elevated free PSA patient samples with Wash Buffer II. " Do not dilute elevated free PSA patient samples using the UniCel DxI onboard dilution feature. " Dilute elevated free PSA samples with Access Hybritech free PSA Calibrator S0 only. " A review of historical patient results is not required because there is no effect on clinical interpretation. * The UniCel DxI onboard dilution feature is only available in limited geographies. " An updated version of the UniCel DxI Assay Protocol File (APF) will remove the Access Hybritech free PSA (dfPSA) onboard dilution assay from the list of available assays. " The Access Hybritech free PSA IFU will be updated to remove Wash Buffer II as an acceptable diluent for elevated patient samples. Correct any procedure manuals or other documents created in your laboratory that list Wash Buffer II as an acceptable diluent for the Access Hybritech free PSA assay. Please share this information with your laboratory staff. If you have forwarded any of the affected product listed above to another laboratory, please provide a copy of the letter to them. Please complete and return the enclosed response form within 10 days so we are certain you received this important communication. If you have any questions regarding this notification, please contact our Customer Support Center " Via our website, http://www.beckmancoulter.com/customersupport/support " Via phone, call 1-800-854-3633 in the United States and Canada Outside the United States and Canada, contact your local Beckman Coulter Representative. We apologize for the inconvenie
Quantity in commerce: 90,965 units total (24,951 units in US)
Distribution: Worldwide Distribution -- USA (nationwide ) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia, Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French, Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libyan, Arab, Jamahiriya, Macao, Mexico, Moldova, Republic of Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, Emirates, United Kingdom, Uruguay ,Venezuela, Viet Nam, Yemen and Zimbabwe.
Product codes and lots: All lots

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)