MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
This recall has been terminated (originally issued June 22, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- May 14, 2007
- Posted
- June 22, 2007
- Terminated
- December 17, 2009
- Recall Number
- Z-0956-2007
- Quantity
- 4,201
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.