Z-2431-2020 Class II Terminated
FDA device recall Z-2431-2020 was initiated by Siemens Healthcare Diagnostics, Inc. on June 5, 2020 and is designated Class II. 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. The recall status is terminated (terminated November 18, 2021). Affected quantity: 1522 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2020
- Initiation Date
- June 5, 2020
- Termination Date
- November 18, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1522 units
Product Description
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 Pattern
US Nationwide Distribution
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