Z-2041-2016Class II

Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of...

Name: Z-2041-2016 Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2016-05-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-05-02 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the... on 2016-05-02. FDA classified it as Class II and gives the reason as "Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2041-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-02
Posted: 2016-06-21
Terminated: 2018-02-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems Cat No. 02789602/SMN 1031 7708 (100 test) Cat No. 02790309/SMN 10317709 (500 test)
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens Healthcare sent an Urgent Medical Device Correction letter dated May 2, 2016, The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to continue use of the affected product, review the letter with their doctor, complete and return the Field Correction Effectiveness Check attached to the letter. If customers received any complaints of illness or adverse events associated wit the affected product they should immediately contact their local Siemens Customer Care Center or their local Siemens technical support representative. Customers with questions should contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 508-668-5000.
Quantity in commerce: SMN 10317708 = 16434 kits and SMN 10317709 = 16033 kits
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to Albania Austria Belgium Bulgaria Burkina Faso Canada Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Polynesia Georgia Germany Great Britain Greece Guadeloupe Hungary Iceland Italy Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Martinique Netherlands Norway Poland Portugal Romania Russian Federation Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey United Arab Emirates and Uzbekistan.
Product codes and lots: All in date lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2041-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2041-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-20

Product code MMI

K053020Class IITnl-Ultra Assay for the Advia Centaur SystemBayer Healthcare, LLC / cleared 2005-12-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)