Recall archive / FDA device enforcement
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Aci... — FDA record Z-0097-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
- Reason
- Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
- Classification
- Class II
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 179 OUS
- Agency-reported status
- Terminated
- Source record identifier
- Z-0097-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Device Identifier: 07613336170076 All serial IDs are affected. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 26, 2022
- Recall initiation date
- Sep 8, 2022
- Center classification date
- Oct 17, 2022
- Termination date
- Nov 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.