—#107659

Product

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.

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K082699
Affected lot / code info: Elecsys Troponin I Immunoassay, 05094810160- lot 163176

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Road, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Worldwide distribution. Argentina, Kenya, Austria, South Korea, Belgium, Kuwait, Bahrain, Morocco, Brazil, Mexico, Switzerland, Nigeria, Chile, New Zealand, Columbia, Philippines, Germany, Pakistan, Algeria, Poland, Egypt, Qatar, Spain, Tunisia, France, Turkey, United Kingdom, Taiwan, India, Ukraine, Iran, Venezuela, Italy, South Africa, Jordan, and Armenia.

Timeline

Recall initiated: 2012-03-12
Posted by FDA: 2012-04-11
Terminated: 2013-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107659. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.