Z-0905-2022Class II

Separation Technology Creamatocrit Plus, Catalog Number: 100-146

Name: Z-0905-2022 Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Creator: Stanbio Laboratory, LP
Published: 2022-03-16
License: https://open.fda.gov/license/

Stanbio Laboratory / initiated 2022-03-16 / Terminated

FDA source

Stanbio Laboratory, LP began a recall of Separation Technology Creamatocrit Plus, Catalog Number: 100-146 on 2022-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0905-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-16
Posted: 2022-04-11
Terminated: 2025-01-02
Recalling firm: Stanbio Laboratory
Product: Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Product code: QEI Breast Milk Macronutrients Test System
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 root 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 [email protected].
Quantity in commerce: 50
Distribution: US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
Product codes and lots: Sold between 2019 and 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0905-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0905-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-20	2022-04-11

Product code QEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)