The Recall Desk
HighFDA (Devices)·Z-0905-2022·Announced 2022-04-20

Breast Milk Analyzer Lacks FDA Validation, Risks Sub-optimal Infant Nutrition

Stanbio Laboratory's Creamatocrit Plus breast milk analyzer was marketed without required FDA 510(k) clearance. Its performance has not been validated, and erroneous results could lead to inadequate nutritional supplementation for infants.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II device with unvalidated performance affecting a vulnerable population (infants), but no illnesses or injuries reported. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, yielding a maximum score of 3.

Plain-English summary

Stanbio Laboratory, LP is recalling the Separation Technology Creamatocrit Plus (Catalog Number: 100-146), a breast milk analyzer distributed nationwide between 2019 and 2021.

The device was marketed as an in-vitro diagnostic (IVD) without FDA 510(k) clearance, which is required before diagnostic devices can legally be marketed in the United States. Because this clearance was not obtained, the device's performance characteristics have not been adequately validated.

Erroneous results from this analyzer could lead to sub-optimal nutrition supplementation for infants.

The recalled product

Product
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Manufacturer
Stanbio Laboratory, LP
Category
Medical Device — Laboratory Diagnostic
Hazard
Affected units
50

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Sold between 2019 and 2021

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

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