Recall archive / FDA device enforcement
Separation Technology Creamatocrit Plus, Catalog Number: 100-146 — FDA record Z-0905-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Separation Technology Creamatocrit Plus, Catalog Number: 100-146
- 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)
- Classification
- Class II
- Recalling firm
- Stanbio Laboratory, LP
- Quantity
- 50
- Agency-reported status
- Terminated
- Source record identifier
- Z-0905-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Sold between 2019 and 2021 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 20, 2022
- Recall initiation date
- Mar 16, 2022
- Center classification date
- Apr 11, 2022
- Termination date
- Jan 2, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.