FDA Device recall Z-2551-2020
MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipettin…
- FDA Device
- Class II
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipettin… by Roche Molecular Systems, citing 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 leadi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2551-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-03 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | All units when used with Sample Transfer protocol version 3.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2551-2020%22
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