FDA Device

Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.

Hazard

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 .

What You Should Do

Remedy

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.

Products

Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions.
Brand
Roche Diagnostics Corp.
UPC
All units.

Units Affected

771 total for recalls Z-1372-1374-06