Recall Z-1830-2016— Roche Molecular Systems, Inc.

Name: FDA recall Z-1830-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-15

Class II · Terminated

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2016-03-15, terminated 2017-12-11. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use. 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)..

Recalling firm: Roche Molecular Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Terminated: 2017-12-11
Firm location: Branchburg, NJ, United States

Product description

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

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.