FDA-Device2015-07-08Class II
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
Roche Diagnostics Operations, Inc.
Hazard
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.
Sold states
US (nationwide) including PR.
Affected count
6255
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1926-2015Don't want to check this manually?
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