Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Reported: May 9, 2018 Initiated: February 26, 2018 #Z-1587-2018
Product Description
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Reason for Recall
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- N/A
- Distribution
- FL and France Spain Sweden United Kingdom Germany
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: N/A.
Why was this product recalled? ▼
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 9, 2018. Severity: Moderate. Recall number: Z-1587-2018.
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