BIOPHEN UFH Control Plasma: Incorrect Labeling Risk
Aniara Diagnostica recalls BIOPHEN UFH Control Plasma due to incorrect product labeling in the package. This may cause confusion with similar products.
Lower-risk recall
Incorrect product labeling was included in the package.
Contact the company
What happened, in plain English
Ani:ara Diagnostica is recalling BIOPHEN UFH Control Plasma because the package includes incorrect labeling. This could lead to confusion with similar products, but does not pose a direct safety risk. Read more at govinfonow.com/recall/60416-biophen-ufh-control-plasma-incorrect-labeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60416-biophen-ufh-control-plasma-incorrect-labeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1743-2022
Cite this page
“BIOPHEN UFH Control Plasma: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60416-biophen-ufh-control-plasma-incorrect-labeling-risk. Based on FDA recall #Z-1743-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1743-2022%22&limit=1).
Why it’s dangerous
The product package contains incorrect labeling, which could cause confusion with similar products. This might lead to using the wrong product in medical settings. However, the labeling issue does not involve physical hazards like fire or injury.
Who’s affected
Users of BIOPHEN UFH Control Plasma are likely affected. Healthcare professionals and lab personnel who handle the product are most at risk due to potential labeling confusion.
How to tell if you have this one
Check for the product name 'BIOPHEN UFH Control Plasma' and the unique identifier 03663537008290 on the package. The lot code FA2035 is also associated with this recall.
- Brand
Aniara Diagnostica- Category
Medical device
What to do — step by step
Check Product Labeling
Verify the product name and unique identifier on the package to confirm it matches the recalled item.
Where it went and when
Where it was distributed
Distributed in Illinois and Michigan.
FDA distribution: “Distribution in US - IL and MI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Michigan.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1743-2022 (June 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1743-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.