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.
What this means for you
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.
- 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
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.
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