Roche Molecular Systems, Inc. recalls cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid…

Recall date

September 8, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0097-2023

FDA classification

Class II

Brand / firm

Roche Molecular Systems, Inc.

Sold / distributed

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.

Why it was recalled

Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.