Z-2404-2020 Class II Ongoing
FDA device recall Z-2404-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on May 7, 2020 and is designated Class II. Reason for recall: Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers. The recall status is ongoing. Affected quantity: 927.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2020
- Initiation Date
- May 7, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 927
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tennessee, Iowa, Rhode Island, South Dakota, New Hampshire, Maryland, Oregon, Indiana, Idaho, Connecticut, Puerto Rico, West Virginia, Washington, Illinois, Utah, Maine, Minnesota, Wyoming, Nevada, Michigan, Missouri, and New Mexico.