Agency classClass IIOur severity:High FDA (Devices)·Z-1622-2015·Announced 2015-05-27

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: inaccurate-results
delayed-diagnosis
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

Distributed nationwide across the United States.

The notice also names 36 states specifically:

Same manufacturer · Roche Diagnostics Operations, Inc.

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