Separation Technology Creamatocrit Plus — Class II medical device recall Z-0905-2022
Terminated recall by Stanbio Laboratory, LP, reported 2022-04-20, distributed nationwide. The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these brea
| Recall number | Z-0905-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stanbio Laboratory, LP, Boerne, TX, United States |
| Recall initiated | 2022-03-16 |
| Classified | 2022-04-11 |
| Reported by FDA | 2022-04-20 |
| Terminated | 2025-01-02 |
| Distributed | Nationwide (US) |
| Quantity | 50 |
| Model numbers | 100-146 |
Product
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0905-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.