—#47078

Product

Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 12236931690 (Return). An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.

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

If the user opens the instrument lid during decontamination, the cycle will stop but the timer will continue resulting in the user believing the instrument has been decontaminated when it has not been.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-07-17
Posted by FDA: 2006-08-05
Terminated: 2007-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #47078. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.