Roche Molecular Systems, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2498-2021)

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 Test for use on the cobas Liat System, Catalog Number 09211101190

Product Classification:

Class II

Date Initiated: August 4, 2021

Date Posted: September 29, 2021

Recall Number: Z-2498-2021

Event ID: 88600

Reason for Recall:

Customers have reported an increased number of false positive SARS-CoV-2 results.

Status: Terminated

Product Quantity: 211 kits (US); 3073 kits (OUS)

Code Information:

Lot 10119Z

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated