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
- Recall Number
- Z-2551-2020
- Event Number
- 85838
- Firm
- Roche Molecular Systems, Inc.
- FEI Number
- 2243471
- Product Code
- JJH
- Status
- Terminated
- Root Cause
- Software change control
- Initiated
- June 3, 2020
- Terminated
- October 4, 2023
- Address
- 1080 US Highway 202 S, Branchburg, NJ, 08876-3733
Description
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.
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.
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.
Worldwide distribution - US Nationwide distribution.
917