FDA recall Z-2431-2020
Siemens Healthcare Diagnostics, Inc. · Class II · device
Product
Atellica CH Chemistry Calibrator
Reason for recall
Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
Distribution
US Nationwide Distribution
Key facts
- Status
- Terminated
- Initiation date
- 2020-06-05
- Report date
- 2020-07-01
- Termination date
- 2021-11-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tarrytown, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2431-2020