—#52324

Product

MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.

FDA product code: NPQ — Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device class: Class 2
Medical specialty: Hematology
Affected 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.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-05-14
Posted by FDA: 2007-06-22
Terminated: 2009-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.