Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Separation Technology Creamatocrit Plus Recalled by Stanbio Laboratory, LP Due to The device was being marketed as an IVD...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stanbio Laboratory, LP directly.
Affected Products
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Quantity: 50
Why Was This 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)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stanbio Laboratory, LP
Stanbio Laboratory, LP has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report