Roche Creatinine Plus Reagent Recalled for Potential Drug Interference
Roche Diagnostics is recalling Creatinine Plus reagent because it may produce falsely decreased results 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 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, and the hazard involves a risk of harm (falsely decreased test results) where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 6,255 analytical units of Creatinine Plus ver. 2. The product is intended for use on COBAS INTEGRA systems, cobas c111, and cobas c systems for the quantitative determination of creatinine concentration in serum, plasma, and urine.
The recall was issued because of possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are 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.
The affected units were distributed nationwide in the US, including Puerto Rico. Affected catalog numbers include 05401470190, 03263991190, 05168589190, and 03263991190. Healthcare facilities should contact the manufacturer for further instructions on how to handle the recalled product.
The recalled product
- Product
- Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
- 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 (4)
- Catalog Numbers: 05401470190
- 03263991190
- 05168589190
- 03263991190.
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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