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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Roche Molecular Systems, Inc.
Lot Codes / Batch Numbers
All units when used with Sample Transfer protocol version 3.0
Products Sold
All units when used with Sample Transfer protocol version 3.0
Roche Molecular Systems, Inc. is recalling MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026