Z-0801-2015Class II

Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum...

Name: Z-0801-2015 Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-10-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-10-27 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of... on 2014-10-27. FDA classified it as Class II. As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0801-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-27
Posted: 2014-12-12
Terminated: 2017-03-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Product code: MMI Immunoassay Method, Troponin Subunit
FDA root cause: Under Investigation by firm
Action: The firm, Siemens, sent an "Urgent Medical Device Recall" letter dated October 27, 2014 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of and discard the kit lots listed; review this letter with your Medical Director, complete and return the Field Correction Effectiveness Check attached to this letter within 7 days via fax to: the Customer Care Center at (312) 275-7795; report any complaints or AE associated with the product to your local Siemens Customer Care Center or your local Siemens technical support representative; contact your local Siemens technical support representative to discuss alternative Siemens solutions; retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, contact your local Siemens technical support representative or 914-524-3074.
Quantity in commerce: 3,622 kits (3,572 domestic and 50 internationally)
Distribution: Worldwide Distribution: US distribution in states of: CO, FL, MN, MT, and NY; and countries of: Algeria, Argentina, Bolivia, Brazil, Bulgaria, Chile, Columbia, Czech Republic, Ecuador, Egypt, Germany, Hungary, India, Italy, Lithuania, Latvia, Pakistan, Poland, Romania, Russian Fed., Serbia, South Africa, Slovakia, Thailand, Tunisia, and Uruguay.
Product codes and lots: Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D); Siemens Material Number (SMN): 1) 10642238 (US) and 2) 10381014 (OUS); Lot Numbers: 319, 321, 322, 323 and D319, D321 and D322.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0801-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0801-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12

Product code MMI

K991795Class IIImmulite Turbo Troponin I, Models Lskti1, Lskti5Diagnostic Products Corp. / cleared 1999-06-09

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)