—#52013

Product

VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K031031
Affected lot / code info: Lots 3151 and 3170

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Drive, Rochester, New York 14626-5101

Distribution

Distribution pattern: Worldwide-including USA, Canada, and Bermuda

Timeline

Recall initiated: 2007-04-27
Posted by FDA: 2007-05-26
Terminated: 2012-09-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.