FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: 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.
- Recall number
- Z-2551-2020
- Recalling firm
- Roche Molecular Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2020-06-03
- Posted
- not on file
- Terminated
- 2023-10-04
- 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.
- Root cause
- Software change control
- Action
- On June 5, 2020, the firm distributed Urgent Medical Device Correction letters to consignee accounts. The UMDC instructs the customers to determine whether or not their laboratory is using the affected Sample Transfer protocol version 3.0 with their MagNA Pure 96 instrument. If the affected protocol is found on the instruments Control Unit, it needs to be immediately deleted by following the instructions provided in the UMDC. A newly updated Sample Transfer protocol version 4.0 is available. Roche Affiliate organizations will provide instructions for obtaining the new version of the protocol. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-1247 if you have questions about this recall.
- Quantity
- 917
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Lot, serial or model codes
- All units when used with Sample Transfer protocol version 3.0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJH
- Firm FEI
- 2243471
- Firm city
- S Branchburg
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28