Exact FDA event identifier

Event 70058

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: December 18, 2014
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Roche Molecular Systems, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.

Z-0999-2015

Recall number: Z-0999-2015
Initiated: December 18, 2014
Classification: Class III
Status: Terminated
Recalling firm: Roche Molecular Systems, Inc.
Quantity: 660 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.

Code information

Lots T10786 T13091, T15435, T15475, T14777, and W00389

Distribution pattern

Foreign Distributed.