Recall archive / FDA device enforcement
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in hu... — FDA record Z-3169-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 15, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 18483 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3169-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00630414596310 Lot Numbers: 232033, 232128, 232137, 232146, 232147, 242149, 242150, 242365 |
Match all identifying details in the current notice. A brand name alone is not enough.
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. ¿¿¿¿¿¿
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 25, 2024
- Recall initiation date
- Aug 15, 2024
- Center classification date
- Sep 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.