Stanbio Laboratory, LP Recall 89829
Description: Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Stanbio Laboratory, LP Recall 89829 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0905-2022 |
| Event ID | 89829 |
| Event Description | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN |
| Quantity | 50 |
| Recall 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) |
| Device Classification | 20220420 |
| Device Code Info | Sold between 2019 and 2021 |
| Center Classification Date | 20220411 |
| Recall Initiation Date | 20220316 |
| Recalling Firm | Stanbio Laboratory, LP |
| Initial Notification | Letter |
| Similar To |