Z-2282-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2020
- Initiation Date
- May 4, 2020
- Termination Date
- September 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1006
Product Description
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.
Reason for Recall
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
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.
Code Information
Lot #s 53149, 53150, 53151, 53152, 53941, 53942, 53943, 53944, 54354, 54371, 54372, 54373, 54374