Device product
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Z-2216-2016
Product summary
- Event
- Event 74094
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-2216-2016
Official wording
Reason: Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
Code information: US-IVD: M1-E-00383 & M1-E-00434
Distribution pattern: Distributed in NC and WA.
Derived failure modes
-
Unknown
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.