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

FDA device recall Z-1645-2012 · posted 2012-05-22 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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

Root cause

Process design

Status

Terminated

Product code

MTG

Quantity affected

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, Col

Date initiated

2011-10-11

Date posted

2012-05-22

Date terminated

2013-03-18

Location

Brea, CA