Recalls / —
—#162990
Product
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
- FDA product code
- JGS — Electrode, Ion Specific, Sodium
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K161954
- Affected lot / code info
- UDI 00630414002439
Why it was 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
Root cause (FDA determination)
Software design
Action the firm took
Recall initiated 02/23/2018 Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Address
- 511 Benedict Ave, Tarrytown, New York 10591-5005
Distribution
- Distribution pattern
- FL and France Spain Sweden United Kingdom Germany
Timeline
- Recall initiated
- 2018-02-26
- Terminated
- 2020-05-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #162990. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.