Roche Diagnostics Operations, Inc. Recall: Homocysteine test system - Homocysteine Reagent
Roche Diagnostics Operations, Inc. Recall: Homocysteine test system - Homocysteine Reagent is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Roche Diagnostics Operations, Inc.; Product: Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS I
| Recalling firm | Roche Diagnostics Operations, Inc. |
|---|---|
| Product | 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. |
| Reason for recall | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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. |
| Recall initiated | 20150323 |
| Recall number | Z-1622-2015 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
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