Lower riskMedical device recall · FDA · Published September 22, 2020
Siemens ADVIA Fructosamine Test Kits May Cause Incorrect Glucose Readings
Siemens Healthcare recalls ADVIA Fructosamine test kits that may show 60 umol/L higher glucose levels than actual, risking incorrect diabetes treatment adjustments. Affected kits have specific Siemens Material Numbers.
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
“Siemens ADVIA Fructosamine Test Kits May Cause Incorrect Glucose Readings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64228-siemens-advia-fructosamine-test-kits-may-cause-incorrect-glucose-readings. Based on FDA recall #Z-0101-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0101-2021%22&limit=1).
The FDA announced on Sept. 22, 2020, that Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Systems-Fructosamine (FRUC) diagnostic kits due to potential positive bias in test results. This error may lead to inappropriate adjustments in hyperglycemic therapy and contribute to hypoglycemia. The recall affects 23 units distributed in the U.S.
How to tell if you have it
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated
UPC: 00630414558073
SMN: 10361941
Lots with UDI ending in 20201128, 20210221, or 20210630
The hazard
Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias compared to the predicate assay reference. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls include the Siemens Atellica CH RCRP Test recall (Aug. 17, 2026), the Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and the Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include the Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor Recall (Nov. 24, 2025) and the Dexcom G7 Sensors Recall (May 27, 2026).
How to tell if you have this one
Check for Siemens Material Number (SMN) 10361941 on the kit. Affected kits were sold with specific Unique Device Identifiers (UDIs) from 2020 to 2021.
Brand
Siemens Healthcare
Product
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated
Category
Medical device
FDA recall event · 2 products
All 2 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
CA, DE, MD, NC, NJ, NY, PA Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Brazil¿¿¿¿ Canada¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ P.R.¿China¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vietnam¿¿¿¿¿¿¿¿
Recall number
Product, codes & lots
Quantity
Z-0101-2021
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941; All lots UDI: (01)00630414558073(10)501874(17)20201128 (01)00630414558073(10)514594(17)20210221 (01)00630414558073(10)528971(17)20210630
US: 23 units; OUS: 204 units
Z-0102-2021
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 11097637; All lots UDI: (01)00630414595580(10)201115(17)20210201 (01)00630414595580(10)201207(17)20210601
US: 28; OUS: 255 units
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for Siemens Material Number (SMN) 10361941 on the test kit.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “CA, DE, MD, NC, NJ, NY, PA Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Brazil¿¿¿¿ Canada¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ P.R.¿China¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Delaware, Maryland, New Jersey, New York, North Carolina, Pennsylvania.
Recall timeline
FDA published this recall 29 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0101-2021 (September 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0101-2021 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.