Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test Recalled by Roche Molecular Systems, Inc. Due to cobas KRAS Mutation Kit T10786 is generating invalid...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Molecular Systems, Inc. directly.
Affected Products
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
Quantity: 660 pieces
Why Was This Recalled?
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Where Was This Sold?
Foreign Distributed.
About Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report