Home / Recalls / Medical Devices
Roche Molecular Systems, Inc. recalls cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Recalled April 1, 2015 · FDA recall Z-1320-2015 · Roche Molecular Systems
Hazard
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661. · FDA Class III
Units
190 kits
Sold at
Foreign
Description
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
Product
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →