medical Class II Updated 2020-06-17

Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista Enzymatic Creatinine, Siemens Material Numbe

Recalled Product

Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - 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 20027AC, 19336AA, 19273AA, 19218AB, 19192AB, 19189AA, 19175AA, ***Updated 8/4/20*** 20083AA ***Updated 11/2/20*** 20128AB 20202AA
View official government recall

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