medical Class II Updated 2020-06-17

Siemens Healthcare Diagnostics, Inc. recalls Dimension Enzymatic Creatinine, Siemens Material Number 1047

Recalled Product

Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - 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 FC0324, BB0262, GD0218, GC0184, FB0122 ***Updated 8/4/20*** GF1006 ***Added 9/10/20*** FB1050 ***Added 11/2/20*** EA1102
View official government recall

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