Recall Z-0801-2015 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
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).
| Date | Dec 12, 2014 (initiated Oct 27, 2014) |
| Status | Terminated |
| Reason | |
| Root cause | Under Investigation by 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 suppor |
| Quantity | 3,622 kits (3,572 domestic and 50 internationally) |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991795 | IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 Diagnostic Products Corp., Jun 9, 1999 |