Z-2254-2016Class II

cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device...

Name: Z-2254-2016 cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device...
Creator: Roche Molecular Systems, Inc.
Published: 2016-04-05
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2016-04-05 / Terminated / root cause: manufacturing process

FDA source

Roche Molecular Systems, Inc. began a recall of cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424... on 2016-04-05. FDA classified it as Class II and gives the reason as "During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2254-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-05
Posted: 2016-07-21
Terminated: 2017-12-11
Recalling firm: Roche Molecular Systems Inc
Product: cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).
Product code: OWD Somatic Gene Mutation Detection System
Reason for recall: During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Roche Molecular Diagnostics sent an Urgent Field Safety Notice letter dated April 5, 2016 to affected customers. Then letter identified the affected product, problem and actions to be taken. The Instructions for use are provided for the user until new ones are available..
Quantity in commerce: 735 devices EGFR; 509 devices cfDNA
Distribution: Foriegn Distribution Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom cfDNA: Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom
Product codes and lots: Lot W08792, Lot W11783, Lot W11438, Lot W14903, Lot W05108. Lot W11435, Lot W12238

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2254-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2254-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-21

Product code OWD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)