cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Reported: June 1, 2016 Initiated: March 15, 2016 #Z-1830-2016
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).
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 8 kits
- Distribution
- Hungary
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use. Recalled by Roche Molecular Systems, Inc.. Units affected: 8 kits.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2016. Severity: Moderate. Recall number: Z-1830-2016.
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