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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72427

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

Open FDA event record

Event summary

Timeline bucket
September 22, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roche Diagnostics Operations, 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

Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

Z-0297-2016
Recall number
Z-0297-2016
Initiated
September 22, 2015
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

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

Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

Code information

During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.

Distribution pattern

Distributed to TX only.