Z-2551-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2020
- Initiation Date
- June 3, 2020
- Termination Date
- October 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 917
Product Description
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 Pattern
Worldwide distribution - US Nationwide distribution.
Code Information
All units when used with Sample Transfer protocol version 3.0