Roche Molecular Systems, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1104-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

Product Classification:

Class II

Date Initiated: December 21, 2022

Date Posted: February 15, 2023

Recall Number: Z-1104-2023

Event ID: 91482

Reason for Recall:

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.

Status: Ongoing

Product Quantity: 18,071 kits (US); 30,085 kits (OUS)

Code Information:

UDI-DI 00875197006674 All in-date lots

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution worldwide.

Voluntary or Mandated:

Voluntary: Firm initiated