Roche Molecular Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0097-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

Product Classification:

Class II

Date Initiated: September 8, 2022

Date Posted: October 26, 2022

Recall Number: Z-0097-2023

Event ID: 90885

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.

Status: Terminated

Product Quantity: 179 OUS

Code Information:

Device Identifier: 07613336170076 All serial IDs are affected.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated