Stanbio Laboratory, LP recalls Separation Technology Creamatocrit Plus, Catalog Number: 100-146

Recall date

March 16, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0905-2022

FDA classification

Class II

Brand / firm

Stanbio Laboratory, LP

Sold / distributed

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

Why it was recalled

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)

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Separation Technology Creamatocrit Plus, Catalog Number: 100-146