Elecsys Troponin I Immunoassay For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction.
Hazard
An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may be as low as 50% of the serum recovery. Correct serum recovery has been confirmed for the affected lots. The issue is caused by the raw material lot (Poly-L-Lysin) instability. Poly-L-Lysin is the
What You Should Do
The firm, Roche Diagnostics Corporation, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 12, 2012 to all customers that received the affected lots of Elecsys Troponin I or Elecsys Troponin I STAT. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the affected product; discard the affected product from their inventory according to their site's local regulations; if their facility has distributed the affected product to other sites, ensure that this letter is provided to those sites; complete and return the attached fax form via fax to 1-888-912-8457 and file this letter for future references. If you have any questions about the information contained in this letter, please contact Roche Diagnostics Technical Support, 24 hours a day, seven days a week at 1-800-428-2336.
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Products
- Brand
- Roche Diagnostics Operations, Inc.
- UPC
- Elecsys Troponin I Immunoassay, 05094810160- lot 163176
Units Affected
739 kits