cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Check against the official notice below — it lists the full affected range.
Roche Molecular Systems is recalling 14 cobas Liat analyzer units used for respiratory virus testing. The affected units have high noise levels in the amber detector, which is used to detect Influenza B. This detector problem increases the likelihood of false positive Influenza B test results. The recalled units were distributed worldwide, including in the U.S. states of Colorado, Illinois, Indiana, Kentucky, Michigan, North Carolina, and Texas, as well as in Cyprus, Spain, and Hong Kong.
The 14 affected units can be identified by their serial numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, and 17086. The source document does not specify what action affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong. Quantity: 14 units Lot/code info: UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.