CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report
Turbo Troponin I For in vitro diagnostic use recalled
Siemens Healthcare Diagnostics is recalling Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin, distributed in Colorado, Florida, Minnesota, Montana, New York. The recall was initiated on 27 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0801-2015
- FDA event ID
- 69718
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Oct 2014
- FDA classified
- 12 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Oct 2014 | Recall initiated by company | |
| 12 Dec 2014 | Classified by FDA | +46 days |
| 24 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Not stated in the enforcement report.
Product as listed by the FDA
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).
Where it was distributed
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.
Questions about this recall
Is Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin recalled?
Yes. Siemens Healthcare Diagnostics recalled Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin on 27 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0801-2015.
Why was it recalled?
The reason has not been published.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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