FDA recall Z-0905-2022

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

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

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