Device product
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Z-0905-2022
Product summary
- Event
- Event 89829
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50
- Official record key
device-enforcement:Z-0905-2022
Official wording
Reason: The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
Code information: Sold between 2019 and 2021
Distribution pattern: US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
Derived failure modes
-
Unknown
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)