medical Class II Updated 2020-07-22

Roche Molecular Systems, Inc. recalls MagNA Pure 96 Instrument, clinical sample concentrator, Mate

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All units when used with Sample Transfer protocol version 3.0
View official government recall

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