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FDAJune 3, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche molecular systemsrocheroche molecular

UPCs

06541089001

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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