Z-0097-2023Class II

cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based...

Name: Z-0097-2023 cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based...
Creator: Roche Molecular Systems, Inc.
Published: 2022-09-08
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2022-09-08 / Terminated

FDA source

Roche Molecular Systems, Inc. began a recall of cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings on 2022-09-08. FDA classified it as Class II and gives the reason as "Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0097-2023
Classification: Class II
Status: Terminated
Initiated: 2022-09-08
Posted: 2022-10-17
Terminated: 2024-11-07
Recalling firm: Roche Molecular Systems Inc
Product: cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Product code: NSU Instrumentation For Clinical Multiplex Test Systems
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.
FDA root cause: Under Investigation by firm
Action: On September 8, 2022, the firm notified all affected customers via an Urgent Field Safety Notice letter. Customers were informed that the issue was attributed to WAKO lenses with a deposit on their surfaces, which can affect the signal in the detection unit. Roche will retrieve and analyze customer's cobas 5800 run data. If the evaluation determines that a lens cleaning is warranted, a service visit will be scheduled. If a lens cleaning is not warranted, no further actions are required. Customers should follow laboratory standard operating procedures to investigate the potential for false positive results for assays where a change in result reporting could impact patient management. In the case of testing for respiratory viruses or blood screening, uncovering false positive results more than one week old would be unlikely to change patient management. In the case of assays used to manage chronic diseases (e.g. hepatitis C) or those used in serial monitoring (e.g. HIV), only the most recent result for a patient would have the potential to affect management. Contact your local affiliate organization if there is any allegation of invalid or false positive results with the cobas 5800 system assays. This device is not currently available in the US.
Quantity in commerce: 179 OUS
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.
Product codes and lots: Device Identifier: 07613336170076 All serial IDs are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0097-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0097-2023	Class II	Terminated	Voluntary: Firm initiated	2022-10-26	2022-10-17

Product code NSU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)