ADVIA Centaur¿ PSA Assay — Class II medical device recall Z-2742-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-09-14, distributed nationwide. Communication provided to emphasize that the PSA values should be interpreted in accordance with current clini
| Recall number | Z-2742-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2016-08-09 |
| Classified | 2016-09-07 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2020-01-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, BH, CH, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HR, HU, IQ, IS, IT, JO, LT, LU, LV, MT, NL, NO, PK, PL, PT, QA, RO, RS, SE, SI, SK, TN, TR |
| Lot numbers | 0063041420300305702271170205, 006304142030031733927, 0063041420300319110272170418, 0063041420300327655272170418SMN, 0063041420300340776268160922, 0063041420300353535268160922, 0063041420300367015269161124, 00630414203003723352691611, 0063041420300382156270161229, 0063041420300387504270161229, 0063041420300393298271170205, 10310293, 16252272, 17339271, 19110272, 24689272, 27655272, 33327272, 39805268, 40776268, 500, 50851268, 53535268, 5702271, 60225269, 67015269, 70205, 71544269, 72335269, 7329271, 81085270, 82156270, 86551270, 87504270, 93298271, 93505271 |
| Model numbers | 06574155/SMN, 10310292 |
Product
ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
Reason for recall
Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2742-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.