Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1931-2015·Announced 2015-07-08

Roche Uric Acid Plus Test Recalled for Drug Interference

Roche Diagnostics is recalling Uric Acid plus ver.2 tests because results may be falsely decreased when used with certain drugs.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential inaccurate test results due to drug interference, which is a moderate risk to patient care but does not involve direct physical injury or death.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 6,255 units of Uric Acid plus ver.2 in vitro tests. These tests are used for the quantitative determination of uric acid in human serum, plasma, and urine on various Roche and Hitachi analyzer systems.

The recall is due to a possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when run with urine samples or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

The affected products were distributed nationwide in the US, including Puerto Rico. Users should contact Roche Diagnostics for further instructions on how to handle the recalled units.

The recalled product

Product: Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: inaccurate-results
drug-interference
Affected units: 6,255

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 (6)

Catalog Numbers:04657608190
03183807190
05171857190
11875426216
11929429216
11929437216.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Same manufacturer · Roche Diagnostics Operations, Inc.

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