Z-2551-2020Class II

MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 -

Name: Z-2551-2020 MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 -
Creator: Roche Molecular Systems, Inc.
Published: 2020-06-03
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2020-06-03 / Terminated / root cause: software

FDA source

Roche Molecular Systems, Inc. began a recall of MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a... on 2020-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2551-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-03
Posted: 2020-07-10
Terminated: 2023-10-04
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.
Product code: JJH Clinical Sample Concentrator
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.
Root cause tag: software
FDA 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 in commerce: 917
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: All units when used with Sample Transfer protocol version 3.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2551-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2551-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-10

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)