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Recall Observatory FDA recall evidence

Device 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.

Z-2283-2020

May 04, 2020

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 85602
Status
Terminated
Classification
Class II
Quantity
1488
Official record key
device-enforcement:Z-2283-2020

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 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

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

    reason.no_named_rule · v1.0.0

    The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.