Recall Z-0754-2016 ยท MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.
| Date | Feb 4, 2016 (initiated Dec 29, 2015) |
| Status | Terminated |
| Reason | PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 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, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.