Z-1830-2016 Class II Terminated
FDA device recall Z-1830-2016 was initiated by Roche Molecular Systems, Inc. on March 15, 2016 and is designated Class II. 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 Preparati… The recall status is terminated (terminated December 11, 2017). Affected quantity: 8 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2016
- Initiation Date
- March 15, 2016
- Termination Date
- December 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 kits
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).
Distribution Pattern
Hungary
Code Information
EGFR v2: 07248563190 cfDNA: 07247737190