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

FDA device recall Z-0097-2023 · posted 2022-10-17 · Terminated

Recall details

Recalling firm

Roche Molecular Systems, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

NSU

Quantity affected

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,

Date initiated

2022-09-08

Date posted

2022-10-17

Date terminated

2024-11-07

Location

S Branchburg, NJ