Z-0097-2023 Class II Terminated
FDA device recall Z-0097-2023 was initiated by Roche Molecular Systems, Inc. on September 8, 2022 and is designated Class II. 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. The recall status is terminated (terminated November 7, 2024). Affected quantity: 179 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2022
- Initiation Date
- September 8, 2022
- Termination Date
- November 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 179 OUS
Product Description
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
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 Pattern
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.
Code Information
Device Identifier: 07613336170076 All serial IDs are affected.