Device product
Atellica CH Chemistry Calibrator
Z-2431-2020
Product summary
- Event
- Event 85844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1522 units
- Official record key
device-enforcement:Z-2431-2020
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: 534179 (including sublots A, B, C, D and E) 911591 (including sublots A, B, and C) UDI: (01)00630414597492(10)534179(17)20211031 (01)00630414597492(10)534179A(17)20211231 (01)00630414597492(10)534179B(17)20211231 (01)00630414597492(10)534179C(17)20220131 (01)00630414597492(10)534179D(17)20220131 (01)00630414597492(10)534179E(17)20220331 (01)00630414597492(10)911591(17)20220331 (01)00630414597492(10)911591A(17)20220531 (01)00630414597492(10)911591B(17)20220531 (01)00630414597492(10)911591C(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.