Device product
Merge LIS software.
Z-0399-2017
Product summary
- Event
- Event 75419
- Status
- Terminated
- Classification
- Class II
- Quantity
- 413 sites potentially have the affected software
- Official record key
device-enforcement:Z-0399-2017
Official wording
Reason: There is a potential for duplicate container numbers to be created for patients.
Code information: Versions: 4.0.1 and earlier.
Distribution pattern: Distribution was made nationwide and to the Virgin Islands. Foreign distribution was made to the Bahamas.
Derived failure modes
-
Unknown
There is a potential for duplicate container numbers to be created for patients.