Siemens Healthcare recalls Atel:lica GGT reagents due to potential low repeatability in lab tests. Affected lots may show inconsistent results on some analyzers. No remedy specified in recall notice.
Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
“Siemens Atellica GGT Reagent Recall: Low Repeatability Risk in Lab Testing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63805-siemens-atellica-ggt-reagent-recall-low-repeatability-risk-in-lab. Based on FDA recall #Z-0722-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0722-2021%22&limit=1).
The FDA announced on November 23, 2020, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica Gamma-Glutamyl Transferase (GGT) Reagent due to low end repeatability issues. The agency issued recall number Z-0722-2021 for the Class II device.
The reagent may demonstrate a coefficient of variation (%CV) outside the performance data for repeatability listed in the Instructions For Use on some analyzers. This low end repeatability imprecision is the primary hazard identified in the recall record.
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), Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Additional recent recalls include Diagnostica Stago STA Staclot Protein S Recall (July 29, 2026), Copan Italia DTT Liquid Reagent Recall (October 29, 2025), and Roche Elecsys Anti-TSHR Assay Recall (November 21, 2025).
How to tell if you have this one
Check for Siemens Material Number (SMN) 11097597 on the reagent packaging. All lot codes are affected. The Unique Device Identifier (UDI) is 00630414596440.
Brand
Siemens Healthcare
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
Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, Vietnam. ¿¿¿¿ ¿¿¿¿¿
Recall number
Product, codes & lots
Quantity
Z-0721-2021
ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL); All lot codes. UDI: 10309495 (20 mL) = 00630414508344 10316298 (70 mL) = 00630414209753
397 units US; 1713 units OUS
Z-0722-2021
Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 11097597; All lot codes. UDI: 00630414596440
731 units US; 16824 units OUS
Based on the official FDA remedy
What to do — step by step
Check Reagent Packaging
Look for Siemens Material Number (SMN) 11097597 and the Unique Device Identifier (UDI) 00630414596440 on the reagent packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt,…” 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 37 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-0722-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0722-2021 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.