ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293

FDA device recall Z-0754-2016 · posted 2016-02-04 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc

Reason for recall

PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).

Action taken

An Urgent Medical Device Correction (UMDC) was sent to all affected Siemens Healthcare Diagnostics customers in the United States on December 30, 2015 to be delivered to customers on December 31, 2015. An Urgent Field Corrective Action (UFCA) was sent out for distribution to all customers outside the United States on December 29, 2015. These notices identified the affected product, problem and actions to be taken. For questions customers were instructed to contact Siemens Customer Care Center or local Siemens technical support representative.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MTF

Quantity affected

55,754 kits

Distribution

Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland

Date initiated

2015-12-29

Date posted

2016-02-04

Date terminated

2019-11-29

Location

East Walpole, MA