Lower riskMedical device recall · FDA · Published February 9, 2022
Siemens Atellica CH Fructosamine Recalled for Quality Control Issues
Siemens Healthcare recalls Atellica CH Fructosamine (Fruc) with material number 11097637 due to potential reagent carryover affecting patient test results. Affected units include specific lot numbers and UDI.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
“Siemens Atellica CH Fructosamine Recalled for Quality Control Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61166-siemens-atellica-ch-fructosamine-recalled-for-quality-control-issues. Based on FDA recall #Z-0930-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2022%22&limit=1).
Siemens Healthcare Diagnostics, Inc. recalled Atellica CH Fructosamine (Fruc) reagents on Feb. 9, 2022, due to potential reagent carryover impacting quality control and patient results, the FDA said. The voluntary Class II recall affects 199 units distributed globally.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH Fructosamine (Fruc)
Siemens Material Number: 11097637
UDI: 00630414595580
Lot Numbers: 211359, 211451
The hazard
Siemens Healthcare Diagnostics Inc. confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 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 (Aug. 17, 2026), Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall: False Results Risk (July 6, 2026). Other recent recalls of similar products include Fructose Intolerance Test Recall (Nov. 3, 2025), Copan Italia DTT Liquid Reagent Recall (Oct. 29, 2025), and HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (Nov. 18, 2025).
How to tell if you have this one
Check for Siemens Material Number 11097637 on the device. Affected units include lot numbers 211359 and 211451, and UDI 00630414595580.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 4 products
All 4 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
Global Distribution. US Nationwide.
Recall number
Product, codes & lots
Quantity
Z-0928-2022
Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644; UDI: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526
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-0930-2022 (February 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0930-2022 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.