Phadia 1000 Model 12-3800-01: Liquid Sensor Error Hazard

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Recalling firmPhadia AbRapsgatan Plant, Rapsgatan 7 · Uppsala, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Phadia is recalling its 1000 model 12-3800-01 instrument because of a liquid sensor error that could lead to inaccurate test results. This affects all units with the specified serial numbers and unique device identifiers.

Why it’s dangerous

The liquid sensor error (code 7-102) can cause inaccurate test results. This may lead to incorrect diagnoses or treatment decisions if the device is used for critical health assessments.

Who’s affected

Healthcare facilities using the Phadia 1000 for immunodiagnostic testing are affected. Patients relying on accurate test results from this device may be at risk.

How to tell if you have this one

Check for the model number 12-3800-01 on the device. All units with the unique device identifier (UDI) 07333066001005 are affected.

Brand
Phadia
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number 12-3800-01 on the device label.
Verify Unique Device Identifier
Confirm the unique device identifier (UDI) 07333066001005 matches your unit.

✎ GovInfoNow

Questions people ask

Is this recall affecting my lab's testing?

Yes, if your lab uses the Phadia 1000 model 12-3800-01 with the unique device identifier 07333066001005, it is affected.

How do I know if my device has the liquid sensor error?

The device may display error code 7-102, indicating a liquid sensor issue.

What should I do if I have this device?

Check the model number and unique device identifier to confirm if your device is affected. No specific action is required beyond verification.

Take action

Contact Phadia

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

✉️ Open in email

Subject: Recall Z-2397-2019 — Phadia Phadia

Hello,

I own a Phadia that is covered by recall Z-2397-2019 from Phadia.

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-2397-2019 (July 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2397-2019 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.

Phadia Ab recalls Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including

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