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Abbott M2000 System – M2000SP Instrument
- Starting date:
- December 10, 2012
- Posting date:
- January 21, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-16827
Recalled Products
- Abbott M2000 System – M2000SP Instrument
Reason
An issue with the M2000SP Instrument Software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the sample extraction assay details screen, the changes are not saved.
Affected products
A. Abbott M2000 System – M2000SP Instrument
Lot or serial number
All Lots
Model or catalog number
9K14-01, 9K14-02
Companies
- Manufacturer
- Abbott Molecular Inc.