FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc: 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)
- Recall number
- Z-2041-2016
- 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)
- Status
- Terminated
- Initiated
- 2016-05-02
- Posted
- not on file
- Terminated
- 2018-02-22
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- All in date lots
- 510(k) numbers
- ["K053020"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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