Z-2405-2020 Class II Ongoing
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
- 1329
Product Description
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
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 Atellica IM1600 analyzers.
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.
Code Information
Atellica Tube Top Sample Cups, 1 mL, SMN 11069061; Atellica Tube Top Sample Cups, 2 mL, SMN 11069062; Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL