FDA recall Z-2551-2020

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.

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.

Distribution

Worldwide distribution - US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2020-06-03

Report date

2020-07-22

Termination date

2023-10-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Branchburg, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2551-2020