Product Wiki · Recalls · U.S. FDA — Device Enforcement

Turbo Troponin I For in vitro diagnostic use for the quantitative… — recall Z-0801-2015

U.S. FDA — Device Enforcement · United States · 2014-10-27 · Class II

As described by U.S. FDA — Device Enforcement: 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).

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0801-2015
Date of alert
2014-10-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
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
Barcode (EAN/GTIN)
10642238
Reported risk: the issuing agency did not publish a reason for this recall. Check the agency notice linked below for the current position.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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