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U.S. Department of Health and Human Services

Class 1 Device Recall VITROS Immunodiagnostic Products Troponin I Reagent Pack

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  Class 1 Device Recall VITROS Immunodiagnostic Products Troponin I Reagent Pack see related information
Date Initiated by Firm April 27, 2007
Date Posted May 26, 2007
Recall Status1 Terminated 3 on September 07, 2012
Recall Number Z-0820-2007
Recall Event ID 37873
510(K)Number K031031  
Product Classification Troponin Reagent - Product Code MMI
Product VITROS¿ Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK
Code Information Lots 3151 and 3170
Recalling Firm/
Manufacturer
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14626-5101
For Additional Information Contact Steve Dnistran
908-218-8287
Manufacturer Reason
for Recall
Quality control and patient results can be lower than expected when the true Troponin I value is less than or equal to 0.2 ng/mL which may result in the device failing to detect myocardial injury.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 4/27/07, Ortho-Clinical Diagnostics in Rochester, NY, notified the end users of the recall of the product by phone, fax, and FedEx overnight letter. Clinical labs in possession of these lots have been contacted by OCD, and were instructed to (a) discontinue use of this product and (b) notify healthcare providers who ordered the test in recent weeks. Replacement product has been provided to clinical labs with the affected product lots. Clinical laboratories with questions may contact the company at 1-800-421-3311. On 4/27/07, OCD foreign affiliates were informed of this action by e-mail and instructed to inform their customers who received these reagent packs of this issue. Ortho-Clinical Diagnostics in Raritan, NJ, issued a nationwide press release on 5/04/07.
Quantity in Commerce Lot 3151: 1,750 units, Lot 3170: 3,316 units
Distribution Worldwide-including USA, Canada, and Bermuda
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MMI and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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