Lower risk Medical device recall · FDA · Published March 5, 2021

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

Siemens Healthcare recalls ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11 due to potential sample identification mismatches with 14-character barcodes. Affected units may require software updates to prevent errors.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1405-2021Medical device Siemens Healthcare ›

Lower-risk recall

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

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Contact the company

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

✎ GovInfoNow plain-language explainer

Siemens Healthcare is recalling ADVIA 2120i hematology analyzers with software versions 6.10 and 6.11 because they may cause sample identification mismatches with 14-character barcodes. This could lead to incorrect lab results if samples are mislabeled. Read more at govinfonow.com/recall/63138-siemens-advia-2120i-software-6-10-6-11-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/63138-siemens-advia-2120i-software-6-10-6-11-risk-of · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1405-2021

Cite this page

“Siemens ADVIA 2120i Software 6.10-6.11: Risk of Sample ID Mismatch.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/63138-siemens-advia-2120i-software-6-10-6-11-risk-of. Based on FDA recall #Z-1405-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1405-2021%22&limit=1).

The FDA announced on March 5, 2021, that Siemens Healthcare Diagnostics, Inc. is recalling ADVIA 2120i (RoHS) Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes. The agency classified the recall as Class II.

How to tell if you have it

Brand: Siemens Healthcare
Product: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer
Software Versions: 6.10 and 6.11
Quantity: 674 units

The hazard

The recall addresses the potential for a Sample Identification (SID) mismatch when using 14-character barcodes with the specified autosampler software versions.

Context

GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (August 17, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall: Risk of Inaccurate Test Results (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall: False Results Risk (July 6, 2026). Other recent recalls of similar products include GEM Premier 5000/7000 Blood Analyzers Risk Patient ID Errors with Bar Code Readers (May 8, 2026), GEM Premier 5000 Blood Analyzer: Risk of Wrong Patient ID Assignment (May 8, 2026), and GEM Premier 5000 Blood Analyzer May Assign Results to Wrong Patient ID (May 8, 2026).

How to tell if you have this one

Check if your ADVIA 2120i hematology analyzer has software versions 6.10 or 6.11. The device is sold by Siemens Healthcare and used in clinical laboratories.

Brand
Siemens Healthcare
Category
Medical device

FDA recall event · 20 products

All 20 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bosnia Herzeg., Botswana, Brazil, Bulgaria, Burkina, Faso, Cambodia, Canada, Chile, Colombia, Croatia, Cura¿ao Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mali Malta, Martinique, Mexico, Namibia, Netherlands, Norway, Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.

Recall number	Product, codes & lots	Quantity
Z-1386-2021	ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414501208	N/A
Z-1387-2021	ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414510309	32 units
Z-1388-2021	ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414581972	1 unit
Z-1389-2021	ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414581989	7 units
Z-1390-2021	ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414581965	15 units
Z-1391-2021	ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414560045	187 units
Z-1392-2021	ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414237879	1 unit
Z-1393-2021	ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414237886	1 unit
Z-1394-2021	ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414019789	8 units
Z-1395-2021	ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11 UDI: 00630414019772	185 units
Z-1396-2021	ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	132 units
Z-1397-2021	ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	283 units
Z-1398-2021	ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	195 units
Z-1399-2021	ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	43 units
Z-1400-2021	ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	969 units
Z-1401-2021	ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	1452 units
Z-1402-2021	ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	33 units
Z-1403-2021	ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	27 units
Z-1404-2021	ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	572 units
Z-1405-2021	ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11; Software Versions 6.10 and 6.11	674 units

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your device's software version by checking the device settings or documentation.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bosnia Herzeg., Botswana, Brazil, Bulgaria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 47 days after the firm started it.

Mar 5, 2021Firm started the recall
Apr 9, 2021FDA classified it Class II
Apr 21, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63138-siemens-advia-2120i-software-6-10-6-11-risk-of">Siemens ADVIA 2120i Software 6.10-6.11: Risk of Sample ID Mismatch (GovInfoNow)</a>

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-1405-2021 (March 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1405-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.