CLASS II Device recall · Reported 22 Jul 2020 · FDA Enforcement Report
MagNA Pure 96 Instrument, clinical sample concentrator recalled
Roche Molecular Systems is recalling MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001, distributed nationwide in the US. The recall was initiated on 3 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2551-2020
- FDA event ID
- 85838
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2020
- FDA classified
- 10 Jul 2020
- Reported
- 22 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Jun 2020 | Recall initiated by company | |
| 10 Jul 2020 | Classified by FDA | +37 days |
| 22 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All units when used with Sample Transfer protocol version 3.0
Where was it sold?
Worldwide distribution - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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