Recall Z-3078-2011 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Roche Diagnostics Operations, Inc.
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 lif
| Date | Aug 29, 2011 (initiated Jul 21, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 148 |
| Distribution | Nationwide Distribution; including the islands of Puerto Rico and Hawaii. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.