Siemens ADVIA 2120 Software 6.10-6.11: Risk of Sample ID Mismatch

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Contact the company & request your remedy

Recalling firmSiemens Healthcare Diagnostics, Inc.511 Benedict Ave, N/A · Tarrytown, NY 10591-5005

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Siemens Healthcare is recalling ADVIA 2120 hematology analyzers with software versions 6.10 and 6.11 because they could cause sample identification mismatches with 14-character barcodes. This might lead to incorrect test results if samples are mislabeled.

Why it’s dangerous

The software versions 6.10 and 6.11 may cause the analyzer to misread 14-character barcodes on samples, leading to incorrect identification of samples. This could result in wrong test results if samples are mislabeled.

Who’s affected

Healthcare facilities using Siemens ADVIA 2120 analyzers with software versions 6.10 or 6.11 are most at risk. Laboratory staff and patients using these systems could be affected by potential mislabeling.

How to tell if you have this one

Check if your ADVIA 2120 hematology analyzer has software versions 6.10 or 6.11. The product includes the Single Aspirate Autosampler (SMN 10316162) model.

Brand
Siemens Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your ADVIA 2120 software version by checking the device settings or documentation.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions 6.10 and 6.11.

How can this cause problems?

The software may misread 14-character barcodes on samples, leading to incorrect sample identification and potential test errors.

Is there a fix available?

The recall record does not specify a remedy, so no immediate fix is mentioned.

Take action

Contact Siemens Healthcare

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

✉️ Open in email

Subject: Recall Z-1396-2021 — Siemens Healthcare Siemens Healthcare

Hello,

I own a Siemens Healthcare that is covered by recall Z-1396-2021 from Siemens Healthcare.

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-1396-2021 (March 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1396-2021 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.

Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10

Lower-risk recall