Recall Z-0097-2023— Roche Molecular Systems, Inc.

Name: FDA recall Z-0097-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-08

Class II · Terminated

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2022-09-08, terminated 2024-11-07. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: Roche Molecular Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-09-08
Terminated: 2024-11-07
Firm location: Branchburg, NJ, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.