FDAFDA · Food and drugs·Recall number Z-1622-2015
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.
Published May 27, 2015 · Recall initiated: March 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- 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.
- Lot
- 05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA Lot number 69781101
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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