Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1923-2015 — 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.

U.S. FDA — Device Enforcement · United States · 2015-05-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1923-2015
Date of alert
2015-05-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Operations, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05401470190
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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