MagNA Pure 96 System Version 1 — Class II medical device recall Z-0536-2014
Terminated recall by Roche Diagnostics Operations, Inc., reported 2013-12-25, distributed in AL, AZ, CA, CT, GA, NC, NJ, NY…. This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software f
| Recall number | Z-0536-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2013-11-25 |
| Classified | 2013-12-18 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-09-04 |
| Distributed | AL, AZ, CA, CT, GA, NC, NJ, NY, OH, TX, VA, WA |
| Quantity | 27 |
| Reason classes | software |
| Serial numbers | 2001, 2002, 2003, 2004, 2006, 2011, 2012, 2013, 2014, 2015, 2016, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 4001, 4022, 4023 and 2 more |
Product
MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.
Reason for recall
This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrument software for sample identification. There is a potential for sample mismatch when using the MagNA Pure 96 IVD instrument (catalog number 06541089001). Importing an order file in xml format to the MagNA Pure 96 IVD instrument software may result in a wrong sequence of samples in the graphical overvi
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-0536-2014. 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.