Recalls / —
—#44998
Product
Roche MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001.
- FDA product code
- NPQ — Test, Factor V Leiden Mutations, Genomic Dna Pcr
- Device class
- Class 2
- Medical specialty
- Hematology
- Affected lot / code info
- All lots.
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 #44998. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.