Lower riskMedical device recall · FDA · Published July 10, 2023
Siemens Atellica CH GGT Test Kits: Potential Reagent Carryover Risk
Siemens Healthcare recalls Atellica CH GGT test kits due to possible reagent carryover causing inaccurate results. Affected kits may lead to incorrect patient test outcomes. Contact for remedy details.
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL Cholesterol (HDLC)
“Siemens Atellica CH GGT Test Kits: Potential Reagent Carryover Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57727-siemens-atellica-ch-ggt-test-kits-potential-reagent-carryover-risk. Based on FDA recall #Z-2473-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2473-2023%22&limit=1).
The FDA announced on July 10, 2023, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Gamma-Glutamyl Transferase-I in vitro diagnostic tests due to potential reagent carryover. This issue may cause positive bias affecting quality control and patient sample results.
The recall addresses potential reagent carryover on the Atellica CH 930 resulting in a positive bias. This bias could impact quality control (QC), patient samples, and calibrator results from Atellica¿CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL Cholesterol (HDLC).
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Recent similar recalls include the Siemens Atellica CH RCRP Test recall (August 17, 2026) and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026). Other recent recalls of similar products include the Copan Italia DTT Liquid Reagent Recall (October 29, 2025), the Roche Elecsys Anti-TSHR Assay Recall (November 21, 2025), and the Magellan LeadCare II Blood Lead Test Kits recall (March 13, 2026).
How to tell if you have this one
Check for the Siemens Material Number (SMN): 11097597 or Unique Device Identification (UDI): 00630414596440 on the test kits. The kits are used for quantitative determination of gamma-glutamyl transferase in human serum and plasma.
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
US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
Recall number
Product, codes & lots
Quantity
Z-2471-2023
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531; Unique Device Identification (UDI): 00630414595818 All Lot Numbers
50148 units
Z-2472-2023
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214; Unique Device Identification (UDI): 00630414611037 All Lot Numbers
6733 units
Z-2473-2023
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597; Unique Device Identification (UDI): 00630414596440 All Lot Numbers
19544 units
Z-2474-2023
Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213; Unique Device Identification (UDI): 00630414610832 All lot numbers
18524 units
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for the Siemens Material Number (SMN): 11097597 or Unique Device Identification (UDI): 00630414596440 on the test kits.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam” 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 58 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-2473-2023 (July 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2473-2023 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.