Z-2281-2020 Class II Terminated
FDA device recall Z-2281-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on May 4, 2020 and is designated Class II. 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. The recall status is terminated (terminated September 20, 2021). Affected quantity: 26.
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
- 26
Product Description
Reason for Recall
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.