Recall Z-0828-2022— Roche Molecular Systems, Inc.

Name: FDA recall Z-0828-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-16

Class II · Ongoing

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2021-11-16. It names one FDA 510(k) clearance: K111387. Product: cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190. Reason: Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results..

Recalling firm: Roche Molecular Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-11-16
Firm location: Branchburg, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K111387 — LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZERIquum, Inc.·cleared 2011-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Reason for recall

Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.

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