Roche Recalls Hungarian Instructions for cobas EGFR Mutation Test Kits
Roche is recalling 8 kits of cobas EGFR Mutation Test v2 and cfDNA Sample Preparation due to errors in the Hungarian translated instructions for use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation error in translated instructions for use, which aligns with the rubric for 'documentation issues' and 'packaging-only problems' classified as Low severity.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 8 kits of the cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation. The recall is limited to the Hungarian translated Instructions for Use for these products.
The recall was initiated because an error was found within the Hungarian translations of the Instructions for Use for the cobas EGFR Mutation Test v2 (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas cfDNA Sample Preparation Kit (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015). The affected products were distributed in Hungary.
The source text does not specify the nature of the error or provide instructions for consumers on how to proceed. Users of these specific kits in Hungary should contact Roche Molecular Systems, Inc. for further information.
The recalled product
- Product
- cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- EGFR v2: 07248563190 cfDNA: 07247737190
Distribution
Distribution scope not specified by the agency.
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