Device product
Phadia 1000 Instrument, Article Number 12-3800-01.
Z-0387-2018
Product summary
- Firm
- Phadia US Inc
- Event
- Event 78752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-0387-2018
Official wording
Reason: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Code information: All versions of the instrument
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.