cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- March 15, 2016
- Terminated
- December 11, 2017
- Recall Number
- Z-1830-2016
- Quantity
- 8 kits
- Firm Location
- Branchburg, NJ
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).
Distribution
Hungary
Lot / Code Info
EGFR v2: 07248563190 cfDNA: 07247737190
Root Cause
Packaging
Action Taken
Roche Molecular Diagnostics Inc. issued an Urgent Field Safety Notice dated March 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Actions to be taken by the customer: " If you have utilized 2 L of DNA PBB during testing of plasma specimens, the samples must be retested using the correct volume (2mL DNA PBB). Communication of this Field Safety Corrective Action This notice must be passed on to all those who need to be aware within your organization or to any organization/individual where the potentially affected devices have been distributed/supplied. Please maintain awareness of this notice and resulting action for an appropriate period to ensure the effectiveness of the corrective action. The undersigned confirms that this notice has been notified to the appropriate Regulatory Agency. For questions regarding this recall call 908-253-7200.