FDA-Device2022-10-26Class II
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Roche Molecular Systems, Inc.
Hazard
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Sold states
International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, UK, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, UAE.
Affected count
179 OUS
Manufactured in
1080 US Highway 202 S, N/A, Branchburg, NJ, United States
Products
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0097-2023Don't want to check this manually?
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