Roche Diagnostics Corp. MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lots 11962700, exp. 8/31/07, 12030400, exp. 6/30/07, 12071100, exp. 9/30/07, 12125800, exp. 10/31/07, 12214300, exp. 12/31/07, 12360200, exp. 3/31/08, 12426200, exp. 4/3008, 12543600, exp. 5/31/08, 12672500, exp. 5/31/08, 12725300, exp. 6/30/08, 12799800, exp. 7/31/08, 12917900, exp. 8/31/08, 13024000, exp. 9/30/08, 13081700, exp. 9/30/08, 13197600, exp. 12/31/08 and 13266600, exp. 2/28/09.
Products Sold
Lots 11962700, exp. 8/31/07; 12030400, exp. 6/30/07; 12071100, exp. 9/30/07; 12125800, exp. 10/31/07; 12214300, exp. 12/31/07; 12360200, exp. 3/31/08; 12426200, exp. 4/3008; 12543600, exp. 5/31/08; 12672500, exp. 5/31/08; 12725300, exp. 6/30/08; 12799800, exp. 7/31/08; 12917900, exp. 8/31/08; 13024000, exp. 9/30/08; 13081700, exp. 9/30/08; 13197600, exp. 12/31/08 and 13266600, exp. 2/28/09.
Roche Diagnostics Corp. is recalling MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001. due to False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined tha. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported.
Recommended Action
Per FDA guidance
Consignees were sent an Urgen Medical Device Correction letter dated 5/14/07 which instructs them to define and establish a lower detection limit, to use UNG to prevent carryover whenever possible, and to confirm low positive results through an independent experiment. A revised device correction letter dated 6/15/07 was subsequently sent to each consignee updating the reason for recall and associated risks.
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