Roche Molecular Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1320-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay

Product Classification:

Class III

Date Initiated: January 13, 2015

Date Posted: April 1, 2015

Recall Number: Z-1320-2015

Event ID: 70355

Reason for Recall:

False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.

Status: Terminated

Product Quantity: 190 kits

Code Information:

T08661

Distribution Pattern:

Foreign

Voluntary or Mandated:

Voluntary: Firm initiated