Reported Dec 24, 2014 · Terminated
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- 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).
- Lot codes and dates
- Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D)
- Siemens Material Number (SMN)1) 10642238 (US) and 2) 10381014 (OUS)
- Lot Numbers
319321322323 and D319D321 and D322
- Amount recalled
- 3,622 kits (3,572 domestic and 50 internationally)
Where it was sold
Why it was recalled
The notice does not describe the hazard.
This product could cause temporary or reversible health problems — stop using it.
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