FDA Device recall Z-2254-2016
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 c…
- FDA Device
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 c… by Roche Molecular Systems, citing during internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative )….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2254-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-05 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Molecular Systems |
| Distribution | n/a |
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).
Reason
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.
Identifiers
| code_info | Lot W08792, Lot W11783, Lot W11438, Lot W14903, Lot W05108. Lot W11435, Lot W12238 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems
FDA Device · Class II · 2023-02-15 · Roche Molecular Systems - cobas 5800 instrument, Material No. 08707464001
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FDA Device · Class II · 2022-04-06 · Roche Molecular Systems
All Roche Molecular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2254-2016%22
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