Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:13775
Brand Name:Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM Version 2.0
Model:5M23-02
Affected:All
Software version:
Recalling Organisation:Abbott Diagnostics Division
Ground Floor, Building D
4 Pacific Rise
Mt Wellington
AUCKLAND 1640
Contact Information:0800 656 233
Manufacturer:Abbott Molecular Inc
Brand Name:Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM version 1.0
Model:5N23-01
Affected:All
Software version:
Recalling Organisation:Abbott Diagnostics Division
Ground Floor, Building D
4 Pacific Rise
Mt Wellington
AUCKLAND 1640
Contact Information:0800 656 233
Manufacturer:Abbott Molecular Inc
Issue:The manufacturer has identified that in the Real Time CMV Application Specification file m2000 CMV Plasma, the upper limits for several processing timers were set such that when samples are run in batch sizes between 49 and 88, the timers on the M2000 may exceed the limits. Consequently sample #49 through the last sample in the run would be tagged with warning code.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:8/11/2012
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