cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2:… — Class II medical device recall Z-2254-2016
Terminated recall by Roche Molecular Systems, Inc., reported 2016-07-27. During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M)
| Recall number | Z-2254-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2016-04-05 |
| Classified | 2016-07-21 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2017-12-11 |
| Countries outside the US | AT, BE, CH, CZ, DE, DK, ES, FR, GB, GR, HR, HU, IT, LT, LU, NL, NO, PL, RO, SI, SK, TR |
| UPC / GTIN / UDI-DI | 00875197005424, 00875197005448 |
| Lot numbers | W05108, W08792, W11435, W11438, W11783, W12238, W14903 |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.