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).
FDA Recall Z-0801-2015 · Posted 2014-12-12
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeMMI
Date Initiated2014-10-27
Date Terminated2017-03-10
Product Quantity3,622 kits (3,572 domestic and 50 internationally)
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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