Z-0905-2022 Class II Terminated
FDA device recall Z-0905-2022 was initiated by Stanbio Laboratory, LP on March 16, 2022 and is designated Class II. Reason for recall: 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 s… The recall status is terminated (terminated January 2, 2025). Affected quantity: 50.
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2022
- Initiation Date
- March 16, 2022
- Termination Date
- January 2, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50
Product Description
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Reason for Recall
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)
Distribution Pattern
US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
Code Information
Sold between 2019 and 2021