VITROS Immunodiagnostic Products Troponin I Reagent Pack 의 리콜

Recall

37873

Class 1

Z-0820-2007

2007-04-27

2007-05-26

Terminated

United States

2012-09-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52013

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.

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.