Z-3170-2024Class II

ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement of...

Name: Z-3170-2024 ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement of...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-08-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-08-15 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/... on 2024-08-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3170-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-15
Posted: 2024-09-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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.
Product code: JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthcare issued Urgent Medical Device Corrections (UMDC) to US consignees ACHC24-05.A.US, ACHC24-05.A.US.CHC on 8/15/24 via FedX and Urgent Field Safety Notices (UFSN)to foreign consignees ACHC24-05.A.OUS, ACHC24-05.A.OUS.CHC to affected customers informing them of the issue and the impact to results. ADVIA Chemistry customers are advised that lot 665399 meets the IFU prozone claim. Customers will be instructed to discontinue use of and discard the impacted reagent lots indicated in the letter. Atellica CH customers will be advised that lots 242194, 242195, and 242321 meet the IFU prozone claim. Customers can continue to use the impacted products, with the understanding that patient samples with values above 9,500 mg/dL (95,000 mg/L) can result in falsely depressed results when using the impacted lots. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution Lot 665399 meets the IFU prozone effect claim. The manufacturing control system has been updated to ensure that there is no impact to future lots. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 19645 units
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. ¿¿¿¿¿¿
Product codes and lots: UDI-DI: 00630414517643 Lot Numbers: 612528, 616644, 620971, 623768, 636498, 640513, 658356, 668872

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3170-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3169-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-18
Z-3170-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-18

Product code JIR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)