Separation Technology Creamatocrit Plus, Catalog Number: 100-146

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)

On 03/16/22, recall notices were mailed to customers who were asked to take the following actions: Stop using the affected device while you review the new Research Use Only labeling included with this letter. If you are using the affected device for research use only, then apply/use the new labeling. If you are using the affected human breast milk analyzer to provide information relating to the nutritional management of infants, then destroy the product in accordance with local regulations. If the affected product was further distributed or forwarded elsewhere, then forward this recall notice to all that need to be aware; alternately, provide a customer contact list so the recalling firm can send this recall notice to these customers. Please complete the Recall Return Response form to the recalling firm. Customers with additional questions are asked to contact Technical Support, Monday through Friday, 8:00 AM to 5:00 PM, Central Time at 1-800-531-5535 or via email at [email protected].