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U.S. Department of Health and Human Services

Class 1 Device Recall Troponin I STAT Immunoassay

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 Class 1 Device Recall Troponin I STAT Immunoassaysee related information
Date Initiated by FirmMarch 12, 2012
Date PostedApril 11, 2012
Recall Status1 Terminated 3 on February 06, 2013
Recall NumberZ-1388-2012
Recall Event ID 61249
510(K)NumberK082699 
Product Classification Immunoassay method, troponin subunit - Product Code MMI
ProductElecsys Troponin I STAT 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.
Code Information Elecsys Troponin I STAT Immunoassay, 05094798160- lot 163177
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis IN 46256-1025
For Additional Information Contact
317-576-2000 Ext. 249
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce1,288 kits
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MMI
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