Z-0609-2016Class II

Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in...

Name: Z-0609-2016 Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in...
Creator: Siemens Healthcare Diagnostics Inc
Published: 2015-11-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-11-11 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071 on 2015-11-11. FDA classified it as Class II and gives the reason as "Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems". 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-0609-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-11
Posted: 2016-01-07
Terminated: 2016-09-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on November 11, 2015 both in the United States and internationally for communication with affected customers. This notice informs customers of the issue and provides mitigation instructions. Customers with questions were advised to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding call 781-269-3000.
Quantity in commerce: 5558
Distribution: Worldwide Distribution - US (nationwide), Algeria, Armenia, Australia, Austria, Bangladesh, Bosnia Herzegovina, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Malaysia, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Product codes and lots: Lot Numbers: 235151002, 235159002, 235166002, 235173002, 235208002 235215002, 235222002, 235229002, 235236002, 235243002 235250002, 235257002, 235278002, 235285002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0609-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0609-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0610-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0611-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0612-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0613-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0614-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0615-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0616-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0617-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0618-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07
Z-0619-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-07

Product code MMI

K051650Class IIStratus Cs Acute Care Mb Isoenzyme of Creatine Kinase (Ckmb) Test Pak; Stratus Cs Acute Care Ckmb Testpak.Dade Behring, Inc. / cleared 2005-09-08

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)