Class II — Stanbio Laboratory, LP
| Recalling firm | STANBIO LABORATORY |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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) |
| Product | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 |
| Quantity | 50 |
| Distribution | US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN |
| Initiated | 2022-03-16 |
| Classified | 2022-04-11 |
| Terminated | 2025-01-02 |
| Recall number | Z-0905-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stanbio Laboratory, LP (Z-0905-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89829/
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