Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Calibrator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADVIA Chemistry Calibrator
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Lots: 534177 (including sublots A
Products Sold
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
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Chemistry Calibrator due to Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Siemens Healthcare Diagnostics sent a letter notification sent to customers dated June 10, 2020. As one of the short-term alternatives for customers, where regulations permit, Siemens has evaluated the use of the lyophilized RANDOX Calibration Serum Level 3 Lot 1024UE. (CAL 3) for generating DBIL_2/DBil_2 and TBIL_2/TBil_2 results until a new lot of unaffected Siemens Chemistry Calibrator is available.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026