FDA Medical Device Recalls (openFDA)
Stanbio Laboratory, LP: Separation Technology Creamatocrit Plus, Catalog Number: 100-146
- Recall number
- Z-0905-2022
- Recalling firm
- Stanbio Laboratory, LP
- Product
- Separation Technology Creamatocrit Plus, Catalog Number: 100-146
- Status
- Terminated
- Initiated
- 2022-03-16
- Posted
- not on file
- Terminated
- 2025-01-02
- Reason
- 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)
- 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 productsafety@ekfdiagnostics.com.
- Quantity
- 50
- Distribution
- US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
- Lot, serial or model codes
- Sold between 2019 and 2021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QEI
- Firm FEI
- 1616487
- Firm city
- Boerne
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28