Separation Technology Creamatocrit Plus, Catalog Number: 100-146 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Lot Codes / Batch Numbers
Sold between 2019 and 2021
Products Sold
Sold between 2019 and 2021
A medical device manufacturer is recalling Separation Technology Creamatocrit Plus, Catalog Number: 100-146 due to The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequate. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026