medical Class II Updated 2020-06-17

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Creatinine_2, Siemens Material Number

Recalled Product

Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - 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 100051, 100025, 100002, 190294, 190256, 190200, 190171, 190135, 190126 ***Added 9/9/20*** 100087 ***Added 11/2/20*** 100109 100136 100167 ***Added 3/11/21*** 110032
View official government recall

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