Z-0754-2016Class II

ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number...

Name: Z-0754-2016 ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2015-12-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-12-29 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of 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... on 2015-12-29. FDA classified it as Class II and gives the reason as "PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0754-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-29
Posted: 2016-02-04
Terminated: 2019-11-29
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.
Product code: MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Reason for recall: PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0754-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0754-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-04

Product code MTF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)