MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. 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.
FDA Recall Z-3078-2011 · Posted 2011-08-29
Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeLXG
Date Initiated2011-07-21
Date Terminated2012-07-02
Product Quantity148
Reason for Recall
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.
Firm Action
Roche Diagnostics Operations, Inc. sent a letter dated July 21, 2011 entitled "URGENT MEDICAL DEVICE CORRECTION" to all affected customers.
The letter included the name product, software versions, and reason for recall and informed them the problem is under investigation. In the meantime, customers are asked to wait 30 seconds after the finalization of the decontamination cycle before initiating the next operation, in order to avoid this issue.
For questions on this recall please call Roche at (800) 428-5074.
Root Cause
Other
Distribution Pattern
Nationwide Distribution; including the islands of Puerto Rico and Hawaii.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.