Roche Molecular Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1830-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 15, 2016

Date Posted: June 1, 2016

Recall Number: Z-1830-2016

Event ID: 73703

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).

Status: Terminated

Product Quantity: 8 kits

Code Information:

EGFR v2: 07248563190 cfDNA: 07247737190

Distribution Pattern:

Hungary

Voluntary or Mandated:

Voluntary: Firm initiated