Recall Z-0820-2007 ยท MMI Immunoassay Method, Troponin Subunit
Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A Troponin Immunoassay Method, IVD. Ortho-Clinical Diagnostics, Amersham UK
| Date | May 26, 2007 (initiated Apr 27, 2007) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | Lot 3151: 1,750 units, Lot 3170: 3,316 units |
| Distribution | Worldwide-including USA, Canada, and Bermuda |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031031 | VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS Ortho-Clinical Diagnostics, Inc., Sep 29, 2003 |