Roche Homocysteine Test System Recalled for Inaccurate Low Results
Roche Diagnostics is recalling Homocysteine Reagent lots due to complaints of under-recovery and falsely low patient results, which could delay diagnosis of peripheral vascular disease.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (delayed diagnosis of peripheral vascular disease) due to inaccurate test results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Homocysteine test system - Homocysteine Reagent (Lot number 69781101). The recall involves 2,558 units of the Homocysteine 100 Tests, cobas c, COBAS INTEGRA, which is an in vitro test used for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
The recall was initiated after customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could lead to inaccurately low Homocysteine results. Because 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 in diagnosis.
The affected product was distributed nationwide, including Puerto Rico 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. Users of the affected reagent lots should stop using the product and contact Roche Diagnostics for further instructions.
The recalled product
- 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.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 2,558
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 05385415190
- Homocysteine 100Tests
- cobas c
- COBAS INTEGRA Lot number 69781101
Distribution
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