—#35979

Product

MagNA Pure LC Instrument; catalog numbers 2236931 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 systems using software version 3.09.

Why it was recalled

Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter dated 11/5/04, which provides the user with a workaround.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2004-11-05
Posted by FDA: 2004-12-08
Terminated: 2005-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35979. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.