CLASS II Device recall · Reported 1 Jun 2016 · FDA Enforcement Report
cobas¿ EGFR Mutation Test, v2 recalled by Roche Molecular Systems
Roche Molecular Systems is recalling cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation. The recall was initiated on 15 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1830-2016
- FDA event ID
- 73703
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2016
- FDA classified
- 26 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Mar 2016 | Recall initiated by company | |
| 26 May 2016 | Classified by FDA | +72 days |
| 1 Jun 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
Where it was distributed
Hungary
Questions about this recall
Is cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation recalled?
Yes. Roche Molecular Systems recalled cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation on 15 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1830-2016.
Why was it 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 lots are affected?
EGFR v2: 07248563190 cfDNA: 07247737190
Where was it sold?
Hungary
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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