Z-1830-2016Class II

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

Name: Z-1830-2016 cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use
Creator: Roche Molecular Systems, Inc.
Published: 2016-03-15
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2016-03-15 / Terminated / root cause: packaging

FDA source

Roche Molecular Systems, Inc. began a recall of cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use on 2016-03-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1830-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Posted: 2016-05-26
Terminated: 2017-12-11
Recalling firm: Roche Molecular Systems Inc
Product: cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use
Product code: OWD Somatic Gene Mutation Detection System
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).
Root cause tag: packaging
FDA root cause: Packaging
Action: 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.
Quantity in commerce: 8 kits
Distribution: Hungary
Product codes and lots: EGFR v2: 07248563190 cfDNA: 07247737190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1830-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1830-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-26

Product code OWD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)