Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
Reported: July 1, 2020 Initiated: May 7, 2020 #Z-2404-2020
Product Description
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 927
- Distribution
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 927.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2404-2020.
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