Lower riskMedical device recall · FDA · Published August 15, 2024
Siemens Atellica Microalbumin Test Kits May Give False Low Results
Siemens Healthcare recalls Atellica CH Microalbumin_2 kits for false low microalbumin readings due to Prozone Effect. Affected units have specific lot numbers and were sold with ADVIA Chemistry systems.
Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.
“Siemens Atellica Microalbumin Test Kits May Give False Low Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54227-siemens-atellica-microalbumin-test-kits-may-give-false-low-results. Based on FDA recall #Z-3169-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3169-2024%22&limit=1).
The FDA announced on August 15, 2024, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Microalbumin_2 (¿ALB_2) reagent kits because they may yield erroneously depressed microalbumin results. The recall affects approximately 18,483 units distributed worldwide.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH Microalbumin_2 (¿ALB_2)
Lot Numbers: 232033, 232128, 232137, 232146, 232147, 242149, 242150, 242365
UDI-DI: 00630414596310
The hazard
The reagent kits do not meet the High-Dose Hook Effect claim or Prozone Effect claim stated in the Instructions for Use. This failure may result in erroneously depressed microalbumin patient results when used on Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems.
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 (August 17, 2026), Siemens Atellica CH Urine Albumin Recall (July 6, 2026), and Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026). Other recent recalls of similar products include Magellan LeadCare II Blood Lead Test Kits, Magellan LeadCare Ultra Blood Lead Test Kit, and Magellan LeadCare Plus Blood Lead Test Kit (all March 13, 2026).
How to tell if you have this one
Check the lot number on the kit packaging. Affected kits have lot numbers 232033, 232128, 232137, 232146, 232147, 242149, 242150, or 242365. They were sold with ADVIA Chemistry systems and Atellica analyzers.
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 and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Canada, Chile, Colombia, Croatia, Cura¿ao, St. Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong¿Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Mexico, Morocco, Netherlands, New¿Zealand, Norway, Oman, P.R.¿China, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Republic¿Korea, Romania, Russian¿Fed., Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E, United¿Kingdom, Uruguay, Vietnam, Zaire. ¿¿¿¿¿¿
Recall number
Product, codes & lots
Quantity
Z-3169-2024
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers; UDI-DI: 00630414596310 Lot Numbers: 232033, 232128, 232137, 232146, 232147, 242149, 242150, 242365
18483 units
Z-3170-2024
ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.; UDI-DI: 00630414517643 Lot Numbers: 612528, 616644, 620971, 623768, 636498, 640513, 658356, 668872
19645 units
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot numbers 232033, 232128, 232137, 232146, 232147, 242149, 242150, or 242365 on the kit 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 and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Canada, Chile, Colombia, Croatia, Cura¿ao, St. Eus, Czech Republic, Denmark, Ecuador,…” 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 41 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-3169-2024 (August 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3169-2024 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.