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 |
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