MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
FDA device recall Z-0956-2007 · posted 2007-06-22 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NPQ
- Quantity affected
- 4,201
- Distribution
- Nationwide.
- Date initiated
- 2007-05-14
- Date posted
- 2007-06-22
- Date terminated
- 2009-12-17
- Location
- Indianapolis, IN
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