MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) Roche Diagnostics Operations, Inc. An automated instrument used f

FDA device recall Z-3078-2011 · posted 2011-08-29 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

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.

Action taken

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

Status

Terminated

Product code

LXG

Quantity affected

148

Distribution

Nationwide Distribution; including the islands of Puerto Rico and Hawaii.

Date initiated

2011-07-21

Date posted

2011-08-29

Date terminated

2012-07-02

Location

Indianapolis, IN