CLASS III Device recall · Reported 7 Nov 2012 · FDA Enforcement Report
cobas 4800 BRAF V600 Mutation Test recalled by Roche Molecular Systems
Roche Molecular Systems is recalling cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems. The recall was initiated on 31 Jul 2012 and the FDA has classified it as Class III.
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-0188-2013
- FDA event ID
- 63310
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 Jul 2012
- FDA classified
- 1 Nov 2012
- Reported
- 7 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 31 Jul 2012 | Recall initiated by company | |
| 1 Nov 2012 | Classified by FDA | +93 days |
| 7 Nov 2012 | 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
It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
Where it was distributed
Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
Questions about this recall
Is cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems recalled?
Yes. Roche Molecular Systems recalled cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems on 31 Jul 2012. The recall is Class III and its status is Terminated. Recall number Z-0188-2013.
Why was it recalled?
It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control
Which lots are affected?
Material number 05985595190; Lot number R03607
Where was it sold?
Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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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