Roche Molecular Systems, Inc.: 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

Is my product affected?

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 inte

• UPC 05985595190

Check against the official notice below — it lists the full affected range.

What happened

Roche Molecular Systems, Inc. is recalling cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 due to incorrect packaging. The test is used for in vitro diagnostic purposes to detect BRAF mutations. The recall involves 44 kits that were distributed worldwide to Australia, Austria, Belgium, China, Hungary, Turkey, and the United Kingdom. Two control batches that were marked as "Internal Use Only" were mistakenly packaged into the kits: batch PV7711 (BRAF Mutant Control) and batch PV0853 (BRAF Wild Type Control). The affected kit has material number 05985595190 and lot number R03607.

The source document does not specify a remedy or what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Distribution: Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom. Quantity: 44 kits Lot/code info: Material number 05985595190; Lot number R03607

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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