The Recall Desk
HighFDA (Devices)·Z-1922-2015·Announced 2015-07-08

Roche Creatinine Plus Reagent Recalled for Potential Drug Interference

Roche Diagnostics is recalling Creatinine Plus reagents because acetaminophen and N-acetylcysteine may cause falsely decreased test results.

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 involves a risk-of-harm product (medical diagnostic reagent) where inaccurate results could impact patient care, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 6,255 analytical units of Creatinine Plus reagents. The product is intended for use on Hitachi/MODULAR systems for the quantitative determination of creatinine concentration in serum, plasma, and urine. The recall was initiated due to a possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers.

The source text indicates that results of Trinder tests may be falsely decreased when run with urine samples (Creatinine Plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. This interference could lead to inaccurate diagnostic results for patients who have recently taken these specific medications.

The affected products were distributed nationwide in the US, including Puerto Rico. The specific catalog numbers involved are 11775685216, 11875566216, and 11875582216. Healthcare facilities and laboratories should check their inventory for these catalog numbers and stop using the affected reagents. Users should contact Roche Diagnostics for further instructions on how to manage the recall and ensure accurate testing.

The recalled product

Product
Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
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 (3)

  • Catalog Numbers: 11775685216
  • 11875566216
  • 11875582216.

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 →

Related recalls

Same manufacturer · Roche Diagnostics Operations, Inc.

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Same hazard · drug interference

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