Recall Z-2742-2016 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
| Date | Aug 9, 2016 |
| Status | Terminated |
| Reason | Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. |
| 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 July 29, 2016 to be delivered to customers on August 1, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on July 28, 2016. These emphasize that the prostate specific antigen (PSA) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy (e.g., the 2013 American Urological Association (AUA) Guidelines or the 2015 |
| Distribution | Nationwide Albania Algeria Angola Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France Georgia Germany Great Britain Greece Hungary Iceland Iraq Italy Jordan Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Netherlands Norway |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.