Device product
ADVIA Chemistry Calibrator
Z-2430-2020
Product summary
- Event
- Event 85844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1872 units
- Official record key
device-enforcement:Z-2430-2020
Official wording
Reason: 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.
Code information: Lots: 534177 (including sublots A, B and C) 960742 UDI: (01)00630414223414(10)534177(17)20210930 (01)00630414223414(10)534177A(17)20211031 (01)00630414223414(10)534177B(17)20211231 (01)00630414223414(10)534177C(17)20220131 (01)00630414223414(10)534177D(17)20220331 (01)00630414223414(10)960742(17)20220531
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.