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Recall Observatory FDA recall evidence

Device product

cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use

Z-1830-2016

March 15, 2016

Class II

Product summary

Firm
Roche Molecular Systems, Inc.
Event
Event 73703
Status
Terminated
Classification
Class II
Quantity
8 kits
Official record key
device-enforcement:Z-1830-2016

Official wording

Reason: 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).

Code information: EGFR v2: 07248563190 cfDNA: 07247737190

Distribution pattern: Hungary

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).