FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
- Recall number
- Z-1320-2015
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
- Status
- Terminated
- Initiated
- 2015-01-13
- Posted
- 2015-03-25
- Terminated
- 2017-12-11
- Reason
- False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.
- Root cause
- Under Investigation by firm
- Action
- RMS notified their customers on 1/13/2015.
- Quantity
- 190 kits
- Distribution
- Foreign
- Lot, serial or model codes
- T08661
- 510(k) numbers
- not on file
- PMA numbers
- ["P120019"]
- Product code
- OWD
- Firm FEI
- 2243471
- Firm city
- S Branchburg
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28