High RiskFDAfda-Z-3305-2024LACERATION

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

Q: What is being recalled?

Siemens Healthcare Diagnostics, Inc. is the subject of a diagnostic devices safety report: Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test). The notice was published on August 21, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 9,783 units are potentially affected.

Q: Why was this product recalled?

This recall was issued in connection with a laceration concern. The full description above contains the FDA's official wording about the defect, affected lots, and impacted distribution — read it carefully.

Q: What should I do if I have this medication or device?

Do not stop, change, or discard a prescribed medication or medical device on your own. Contact your doctor or pharmacist immediately to ask whether the recall applies to your prescription and what to do next. Abruptly stopping certain medications can be dangerous. For the official FDA notice and contact information, visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts.

Q: Is the FDA telling me to stop using it?

Any specific instructions come directly from the FDA's official notice (shown above). Product Recall Tracker does not provide medical guidance. If the FDA's notice says to stop using the product, follow up with your prescriber or pharmacist before making any change — they can advise on alternatives that are safe for your situation.

Q: Has anyone been hurt by this product?

Injury and incident reports are part of the official recall announcement above. If you or a member of your household has been harmed by this product, seek medical attention and report the incident to FDA at https://www.fda.gov/safety/report-problem-fda. Reports help the agency identify ongoing risks and pursue follow-up enforcement.

Q: Where can I get more information?

The U.S. Food and Drug Administration (FDA) is the authoritative source for this recall. Visit https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts for the complete recall notice, lot codes, and the manufacturer's contact information. For personal medical guidance, consult your doctor or pharmacist.

Q: Why doesn't this page give me medical advice?

Product Recall Tracker is a public index of FDA recall data — not a medical resource. We can show you what the FDA published, but we are not qualified to advise you on whether to take, stop, or substitute a medication or use a medical device. Your doctor and pharmacist know your medical history and can give safe, personalized guidance. Please call them with any questions about your treatment.

Brand

Siemens Healthcare Diagnostics, Inc.

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3305-2024.

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3305-2024.

Recall ongoing. Follow firm instructions.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

Do not stop, change, or discard your prescription on your own.
Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
Follow your clinician's guidance on whether to continue, switch, or return the product.
If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3305-2024.

Siemens Healthcare Diagnostics, Inc.

Official Source

FDA Recalls

U.S. Food and Drug Administration

Report an Incident

File a Complaint

Reports inform future enforcement

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

Visit FDA.gov →

📣 Report an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

How to report to FDA →File a report at FDA →

Siemens Healthcare Diagnostics, Inc. Recall FAQ

What is being recalled?

Siemens Healthcare Diagnostics, Inc. is the subject of a diagnostic devices safety report: Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test). The notice was published on August 21, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 9,783 units are potentially affected.

Why was this product recalled?

What should I do if I have this medication or device?

Is the FDA telling me to stop using it?

Has anyone been hurt by this product?

Where can I get more information?

Why doesn't this page give me medical advice?

Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

FDA Recall Notice

Corrective Action (per FDA)

🩺 Talk to your doctor or pharmacist

Consumer Contact (per FDA)

About the U.S. Food and Drug Administration

📣 Report an adverse event to the FDA (MedWatch)

Siemens Healthcare Diagnostics, Inc. Recall FAQ

Other recalls from Siemens Healthcare Diagnostics, Inc.

Other diagnostic devices recalls