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

Hazard

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

Details from the source

Reason for recall: Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses. Distribution: 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. Quantity: 179 OUS Lot/code info: Device Identifier: 07613336170076 All serial IDs are affected.

UPC codes

07613336170076

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.