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.

Recall number

Z-0097-2023

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.

Status

Terminated

Initiated

2022-09-08

Posted

2022-10-17

Terminated

2024-11-07

Reason

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

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

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.

Lot, serial or model codes

Device Identifier: 07613336170076 All serial IDs are affected.

510(k) numbers

not on file

PMA numbers

not on file

Product code

NSU

Firm FEI

2243471

Firm city

S Branchburg

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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