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Recall Observatory FDA recall evidence

Device product

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

June 03, 2020

Class II

Product summary

Firm
Roche Molecular Systems, Inc.
Event
Event 85838
Status
Terminated
Classification
Class II
Quantity
917
Official record key
device-enforcement:Z-2551-2020

Official wording

Reason: 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.

Derived failure modes

  • 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.