Recall Z-1622-2015 ยท LPS Urinary Homocystine (Nonquantitative) Test System
Roche Diagnostics Operations, Inc.
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
| Date | May 15, 2015 (initiated Mar 23, 2015) |
| Status | Terminated |
| Reason | Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di |
| Root cause | Nonconforming Material/Component |
| Action | Roche Diagnostics sent URGENT MEDICAL DEVICE CORRECTION notifications dated 3/23/2015 to affected direct accounts via UPS. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions. |
| Quantity | 2558 units |
| Distribution | Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113793 | HOMOCYSTEINE TEST Roche, Jun 5, 2012 |