BIOPHEN UFH Control C2 Recall: Incorrect Instructions for Use in Specific Lots

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Recalling firmAniara Diagnostica LLC7768 Service Center Dr, N/A · West Chester, OH 45069-2442

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Aniara Diagnostica is recalling specific lots of BIOPHEN UFH Control C2 devices due to incorrect Instructions for Use being packaged. This could lead to confusion during device operation, though it does not pose a direct safety risk.

Why it’s dangerous

Incorrect Instructions for Use were packaged into specific lots of the BIOPHEN UFH Control C2 device. This could cause confusion during device operation, but does not involve physical harm or malfunction.

Who’s affected

Users of BIOPHEN UFH Control C2 devices with specific lot numbers (F1700315P7) are affected. Healthcare professionals using these devices are most at risk.

How to tell if you have this one

Check the lot number on the device packaging. The affected lot is F1700315P7 for BIOPHEN UFH Control C2 (REF 223901).

Brand
Aniara Diagnostica
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for the lot number on the device packaging to determine if it is affected (F1700315P7).

✎ GovInfoNow

Questions people ask

What is the specific lot number that needs to be checked?

The affected lot number is F1700315P7 for BIOPHEN UFH Control C2 (REF 223901).

Is there a remedy for this recall?

The recall record does not specify a remedy.

Could this cause injury?

The recall states incorrect Instructions for Use were packaged, but it does not indicate a risk of injury.

Take action

Contact Aniara Diagnostica

We’ve drafted a message you can send Aniara Diagnostica to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1188-2019 — Aniara Diagnostica Aniara Diagnostica

Hello,

I own a Aniara Diagnostica that is covered by recall Z-1188-2019 from Aniara Diagnostica.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1188-2019 (March 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1188-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.

Aniara Diagnostica LLC recalls BIOPHEN UFH Control C2, REF 223901

Lower-risk recall