FDA Device recall Z-0905-2022
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
- FDA Device
- Class II
- terminated
- Published 2022-04-20
On 2022-04-20 the FDA classified a Class II recall of Separation Technology Creamatocrit Plus, Catalog Number: 100-146 by Stanbio Laboratory, citing 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 re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0905-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-16 |
| Published | 2022-04-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stanbio Laboratory |
| Distribution | US |
Product
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
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)
Identifiers
| code_info | Sold between 2019 and 2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0905-2022%22
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