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.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling 2,558 units of Homocysteine Reagent (Lot number 69781101) used in the cobas c and COBAS INTEGRA Homocysteine Enzymatic Assay test systems. Customers reported that certain lots of this reagent showed under-recovery of non-Roche controls and produced discrepant low patient results, creating a negative bias in test measurements. The product was distributed nationwide across multiple states and Puerto Rico.
The concern with this reagent is that it could produce inaccurately low Homocysteine results. Because elevated Homocysteine levels are an important risk factor in assessing peripheral vascular disease, falsely low values could delay diagnosis of this condition. The recall record does not specify a remedy or required consumer action.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 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. Quantity: 2558 units Lot/code info: 05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.