Roche Molecular Systems, Inc. recalls cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
- Recall date
- March 15, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1830-2016
- FDA classification
- Class II
- Brand / firm
- Roche Molecular Systems, Inc.
- Sold / distributed
- Hungary
Why it was recalled
An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
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