MagNA Pure 96 Instrument — Class II medical device recall Z-2551-2020
Terminated recall by Roche Molecular Systems, Inc., reported 2020-07-22, distributed nationwide. When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instru
| Recall number | Z-2551-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2020-06-03 |
| Classified | 2020-07-10 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2023-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 917 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2551-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.