Stanbio Laboratory, LP: Medical Device Recall in 2022 - (Recall #: Z-0905-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Separation Technology Creamatocrit Plus, Catalog Number: 100-146

Product Classification:

Class II

Date Initiated: March 16, 2022

Date Posted: April 20, 2022

Recall Number: Z-0905-2022

Event ID: 89829

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)

Status: Terminated

Product Quantity: 50

Code Information:

Sold between 2019 and 2021

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated