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Stanbio Laboratory, LP recalls Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Recalled April 20, 2022 · FDA recall Z-0905-2022 · Stanbio Laboratory
Hazard
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) · FDA Class II
Units
50
Sold at
US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
Description
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)
Product
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Manufacturer(s)
Stanbio Laboratory, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →