Class 2 Device Recall StanBio Laboratory Creamatocrit Plus

• Date Initiated by Firm: March 16, 2022
• Create Date: April 11, 2022
• Recall Status: Terminated on January 02, 2025
• Recall Number: Z-0905-2022
• Recall Event ID: 89829
• Product Classification: Breast milk macronutrients test system - Product Code QEI
• Product: Separation Technology Creamatocrit Plus, Catalog Number: 100-146
• Code Information: Sold between 2019 and 2021
• FEI Number: 1616487
• Recalling Firm/ Manufacturer: Stanbio Laboratory, LP; 1261 N Main St; Boerne TX 78006-3014
• For Additional Information Contact: 830-249-0772
• Manufacturer Reason for Recall: 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 Determined Cause: No Marketing Application
• Action: 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 productsafety@ekfdiagnostics.com.
• Quantity in Commerce: 50
• Distribution: US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.