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BD MAX SYSTEM SOFTWARE V4.44A(2015-07-30)
- Starting date:
- July 30, 2015
- Posting date:
- August 24, 2015
- 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-54786
Affected Products
A. BD MAX SYSTEM SOFTWARE V4.44A
Reason
BD Max System Software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (OSR) customers utilizing user defined protocol (UDP) assays. Customers utilizing only IVD assays are not affected. This anomaly may cause OSR customer system to incorrectly switch the columns of the truth table on the user's display. If the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting.
Affected products
A. BD MAX SYSTEM SOFTWARE V4.44A
Lot or serial number
N/A
Model or catalog number
441916
Companies
- Manufacturer
-
Becton Dickinson and Company
7 Loveton Circle
Sparks
Maryland
UNITED STATES