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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85838

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

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Event summary

Timeline bucket
June 03, 2020
Product types
Device
Classifications
Class II
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

MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.

Z-2551-2020
Recall number
Z-2551-2020
Initiated
June 03, 2020
Classification
Class II
Status
Terminated
Quantity
917

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results.

Code information

All units when used with Sample Transfer protocol version 3.0

Distribution pattern

Worldwide distribution - US Nationwide distribution.