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.

Recall number

Z-0754-2016

Recalling firm

Siemens Healthcare Diagnostics, Inc

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.

Status

Terminated

Initiated

2015-12-29

Posted

2016-02-04

Terminated

2019-11-29

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, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, Turkmenistan, Unit.Arab Emir., Vatican, AR, AU, BD, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IL, IN, JP, KR, LK, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN and ZA.

Lot, serial or model codes

SMN 10310292-100 test kits Lot# UDI # 54637263 0063041420300354637263160223 55304263 0063041420300355304263160223 56249264 0063041420300356249264160327 76727264 0063041420300376727264160327 00825265 0063041420300300825265160424 92416265 0063041420300392416265160424 99151265 0063041420300399151265160424 12970266 0063041420300312970266160721 14158266 0063041420300314158266160721 23016266 0063041420300323016266160721 28881266 0063041420300328881266160721 40776268 0063041420300340776268160922  SMN 10310293-500 test kits Lot# UDI # 54448263 0063041420299054448263160223 55171263 0063041420299055171263160223 56171264 0063041420299056171264160327 77560264 0063041420299077560264160327 92415265 0063041420299092415265160424 96996265 0063041420299096996265160424 12971266 0063041420299012971266160721 13429266 0063041420299013429266160721 19651266 0063041420299019651266160721 27278266 0063041420299027278266160721 35089266 0063041420299035089266160721 39805268 0063041420299039805268160922 50851268 0063041420299050851268160922

510(k) numbers

not on file

PMA numbers

["P950021S006"]

Product code

MTF

Firm FEI

1219913

Firm city

East Walpole

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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