Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
cobas 5800 instrument Recalled by Roche Molecular Systems, Inc. Due to Reported false positive and invalid results on the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Molecular Systems, Inc. directly.
Affected Products
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Quantity: 179 OUS
Why Was This Recalled?
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Where Was This Sold?
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.
About Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report