Lower riskMedical device recall · FDA · Published March 16, 2022
Stanbio Creamatocrit Plus: Erroneous Breast Milk Results Risk
Stanbio recalls Creamatocrit Plus breast milk analyzers (2019-2021) due to unvalidated performance as an IVD, risking suboptimal infant nutrition. Affected users should contact for remedy.
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)
Take action
Contact the company
📍Recalling firmStanbio Laboratory, LP1261 N Main St · Boerne, TX 78006-3014
“Stanbio Creamatocrit Plus: Erroneous Breast Milk Results Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/60928-stanbio-creamatocrit-plus-erroneous-breast-milk-results-risk. Based on FDA recall #Z-0905-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0905-2022%22&limit=1).
Stanbio Laboratory, LP recalled Separation Technology Creamatocrit Plus (Catalog Number 100-146) because the device was marketed as an in vitro diagnostic without required FDA clearance, according to the Food and Drug Administration. The recall was announced on March 16, 2022.
How to tell if you have it
Brand: Stanbio
Product: Separation Technology Creamatocrit Plus
Catalog Number: 100-146
Sold between 2019 and 2021
The hazard
The FDA stated that the 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).
Context
GovInfoNow's records show Stanbio Laboratory, LP has issued four other recalls since February 8, 2018. On October 2, 2023, the company recalled STAT-Site M BHB Test Strips due to false negative risk. Other recent recalls of similar products include Vivoo Test Strips Recall (November 22, 2025), Vivoo Protein Test Recall (November 22, 2025), and Vivoo Vaginal pH Test Recall (November 22, 2025).
How to tell if you have this one
Check for the catalog number 100-146 on the device. The Creamatocrit Plus was sold between 2019 and 2021.
Brand
Stanbio
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Stanbio
Reach out to Stanbio Laboratory for instructions on how to handle the device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution CA, TX, OK, SD, IL, NV, MO, FL, WA, KY, WI, PA, NC, GA, MD, MN” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, Nevada, North Carolina, Oklahoma, Pennsylvania, South Dakota, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0905-2022 (March 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0905-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.