—#44912

Product

Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001

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

Why it was recalled

The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter dated 4/4/06 to notify customers of the problem and provide a work-around.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-04-04
Posted by FDA: 2006-04-19
Terminated: 2006-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #44912. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.