Siemens Recalls Turbo Troponin I Diagnostic Kits for Potential Diagnostic Errors
Siemens Healthcare Diagnostics is recalling 3,622 Turbo Troponin I kits used to diagnose heart attacks due to a Class II safety concern.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is voluntarily recalling 3,622 kits of the Turbo Troponin I in vitro diagnostic product. The product is used for the quantitative measurement of troponin I in serum, heparinized, or EDTA plasma to aid in the diagnosis of acute myocardial infarction (AMI). The recall was initiated by the firm on October 27, 2014, and was classified as Class II by the FDA.
The affected products include catalog numbers LSKTI1 and LSKTI1(D), with Siemens Material Numbers 10642238 (US) and 10381014 (OUS). Specific lot numbers involved are 319, 321, 322, 323, D319, D321, and D322. The recall covers 3,572 kits distributed domestically in the United States and 50 kits distributed internationally.
Domestic distribution occurred in Colorado, Florida, Minnesota, Montana, and New York. International distribution included 27 countries, including Algeria, Argentina, Brazil, Germany, India, and Italy. The recall was terminated on March 10, 2017. Users should check their inventory for the specific catalog and lot numbers listed and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- 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).
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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.
Distribution
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