Product Safety Recalls

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Stanbio Laboratory, LP Recall 89829

Description: Separation Technology Creamatocrit Plus, Catalog Number: 100-146

Stanbio Laboratory, LP Recall 89829 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0905-2022
Event ID89829
Event DescriptionSeparation Technology Creamatocrit Plus, Catalog Number: 100-146
Product TypeDevices
DistributionUS Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
Quantity50
Recall ReasonThe 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)
Device Classification20220420
Device Code InfoSold between 2019 and 2021
Center Classification Date20220411
Recall Initiation Date20220316
Recalling FirmStanbio Laboratory, LP
Initial Notification Letter
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