medical Class II Updated 2020-06-17

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Num

Recalled Product

ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.


Hazard / Issue

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #s 53149, 53150, 53151, 53152, 53941, 53942, 53943, 53944, 54354, 54371, 54372, 54373, 54374
View official government recall

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