Stanbio Laboratory, LP recalls Separation Technology Creamatocrit Plus, Catalog Number: 100
Recalled Product
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Hazard / Issue
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)
Issued by
FDA
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