Company: Roche Diagnostics Operations, Inc.
Date of Enforcement Report 9/21/11
Class ll:
PRODUCT
1) MagNA Pure LC 1.0 (software version 3.0.11). An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes. Series 1.0 software version 3.0.11, Part number 12236931001. Recall # Z-3077-2011;
2) MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24). An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes. Part number 05197686001. Recall # Z-3078-2011
REASON
Roche has detected a problem with the MagNA Pure LC 1.0 (software version 3.0.11) and the MagNA Pure LC 2.0 (software versions 1.1.23 and 1.1.24) instruments. Under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN, letter dated July 21, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
570 units
DISTRIBUTION
Nationwide and PR
