medical Class II Updated 2022-08-10

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use i

Recalled Product

Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.


Hazard / Issue

Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Unique Device Identification (UDI): 00630414596402 All lots
View official government recall

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