cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche… — Class III medical device recall Z-0188-2013
Terminated recall by Roche Molecular Systems, Inc., reported 2012-11-07. It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas
| Recall number | Z-0188-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2012-07-31 |
| Classified | 2012-11-01 |
| Reported by FDA | 2012-11-07 |
| Terminated | 2013-09-11 |
| Countries outside the US | AT, AU, BE, CN, GB, HU, TR |
| Quantity | 44 kits |
| Lot numbers | R03607 |
Product
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).
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0188-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.