FDA Device recall Z-2742-2016
ADVIA Centaur¿ PSA Assay
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of ADVIA Centaur¿ PSA Assay by Siemens Healthcare Diagnostics, citing communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2742-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-09 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
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.
Identifiers
| code_info | SMN 10310292 - 100 test kits Lot# UDI# 40776268 0063041420300340776268160922 53535268 0063041420300353535268160922…SMN 10310292 - 100 test kits Lot# UDI# 40776268 0063041420300340776268160922 53535268 0063041420300353535268160922 67015269 0063041420300367015269161124 72335269 00630414203003723352691611 24 82156270 0063041420300382156270161229 87504270 0063041420300387504270161229 93298271 0063041420300393298271170205 5702271 0063041420300305702271170205 17339271 006304142030031733927 11 70205 19110272 0063041420300319110272170418 27655272 0063041420300327655272170418 SMN 10310293- 500 test kits Lot# 39805268 50851268 60225269 71544269 81085270 86551270 93505271 7329271 16252272 24689272 33327272 UDI# 0063041420299039805268160922 0063041420299050851268160922 0063041420299060225269161124 0063041420299071544269161124 0063041420299081085270161229 0063041 420299086551270161229 0063041 420299093505271 170205 0063041420299007329271 170205 0063041420299016252272170418 0063041420299024689272170418 0063041420299033327272170418 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2742-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.