Roche Molecular Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1413-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190

Product Classification:

Class II

Date Initiated: March 25, 2021

Date Posted: April 21, 2021

Recall Number: Z-1413-2021

Event ID: 87622

Reason for Recall:

Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves

Status: Ongoing

Product Quantity: US: 143,823 kits Ex-US: 57,219 kits

Code Information:

All lot numbers

Distribution Pattern:

Nationwide WorldWide

Voluntary or Mandated:

Voluntary: Firm initiated