# FDA recall Z-0905-2022

> **Stanbio Laboratory, LP** · Class II · device recall initiated 2022-03-16.

## 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)

## Distribution

US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN

## Key facts

- **Recall number:** Z-0905-2022
- **Recalling firm:** Stanbio Laboratory, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-16
- **Report date:** 2022-04-20
- **Termination date:** 2025-01-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boerne, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0905-2022

## Citation

> AI Analytics. FDA recall Z-0905-2022. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0905-2022. Source: US FDA. Licensed CC0.

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