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Recall Observatory FDA recall evidence

Device 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.

Z-1622-2015

March 23, 2015

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 71034
Status
Terminated
Classification
Class II
Quantity
2558 units
Official record key
device-enforcement:Z-1622-2015

Official wording

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

Code information: 05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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