Device 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.
Z-2282-2020
Product summary
- Event
- Event 85602
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1006
- Official record key
device-enforcement:Z-2282-2020
Official wording
Reason: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Code information: Lot #s 53149, 53150, 53151, 53152, 53941, 53942, 53943, 53944, 54354, 54371, 54372, 54373, 54374
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of North Carolina, California, Indiana, Florida, Ohio, Arizona, Massachusetts, New Jersey, New Hampshire, Illinois, Minnesota, Arkansas, New York, Delaware, Nevada, Kentucky, Washington DC, Montana, Missouri, Colorado, Maryland, Tennessee, Oregon, Virginia, Iowa, Wisconsin, Louisiana, Georgia, Pennsylvania, North Dakota, Mississippi, South Dakota, Washington, Nebraska, Texas, Alaska, Puerto Rico, Idaho, Oregon, Maine, Vermont, West Virginia, Kansas.
Derived failure modes
-
Unknown
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.