Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ At

Hazard

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.

Details from the source

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. 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, Latv Quantity: 19645 units Lot/code info: UDI-DI: 00630414517643 Lot Numbers: 612528, 616644, 620971, 623768, 636498, 640513, 658356, 668872

UPC codes

00630414517643

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.