Roche Molecular Systems, Inc. recalls cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
- Recall date
- January 13, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1320-2015
- FDA classification
- Class III
- Brand / firm
- Roche Molecular Systems, Inc.
- Sold / distributed
- Foreign
Why it was recalled
False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
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