Reported Apr 20, 2022 · Terminated
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Stanbio Laboratory, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stanbio Laboratory, LP · 1261 N Main St · Boerne, TX · 78006-3014
Is this the product you have?
- Separation Technology Creamatocrit Plus
- Catalog Number100-146
- Lot codes and dates
- Sold between 2019 and 2021
- Amount recalled
- 50
Where it was sold
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)
This product could cause temporary or reversible health problems — stop using it.
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