ADVIA Centaur PSA Assay — Class II medical device recall Z-0754-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-02-10, distributed nationwide. PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
| Recall number | Z-0754-2016 |
|---|---|
| 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 | 2015-12-29 |
| Classified | 2016-02-04 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2019-11-29 |
| 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, LB, LT, LU, LV, MA, MT, NL, NO, OM, PH, PK, PL, PT, QA, RO, RS, SE, SI, SK, TN, TR |
| Quantity | 55,754 kits |
| Reason classes | potency |
| Lot numbers | 0063041420299012971266160721, 0063041420299013429266160721, 0063041420299019651266160721, 0063041420299027278266160721, 0063041420299035089266160721, 0063041420299039805268160922, 0063041420299050851268160922, 0063041420299054448263160223, 0063041420299055171263160223, 0063041420299056171264160327, 0063041420299077560264160327, 0063041420299092415265160424, 0063041420299096996265160424, 0063041420300300825265160424, 0063041420300312970266160721, 0063041420300314158266160721, 0063041420300323016266160721, 0063041420300328881266160721, 0063041420300340776268160922SMN, 0063041420300354637263160223, 0063041420300355304263160223, 0063041420300356249264160327, 0063041420300376727264160327, 0063041420300392416265160424, 0063041420300399151265160424, 00825265, 10310293-500, 12970266, 12971266, 13429266, 14158266, 19651266, 23016266, 27278266, 28881266, 35089266, 39805268, 40776268, 50851268, 54448263 and 11 more |
| Model numbers | 02676506/SMN, 06574155/SMN, 10310292, 10310293 |
Product
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.
Reason for recall
PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
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-0754-2016. 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.