ADVIA Chemistry Calibrator recallZ-2430-2020 · Siemens Healthcare Diagnostics, Inc. · initiated Jun 5, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2430-2020
- Status
- Terminated
- Initiated by the company
- Jun 5, 2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1872 units
- Product code
- NDW
- FDA submissions
- K050374
- Distribution
- US Nationwide Distribution
Product description
ADVIA Chemistry Calibrator
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ADVIA® Chemistry Calibrator 10312279Siemens Healthcare Diagnostics Inc. · CALIBRATOR, MULTI-ANALYTE MIXTURE1 recall3 reports
Other devices under the same FDA submission
2 devices cleared under K050374 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Atellica CH Lithium_2 (LITH_2) 11532401Siemens Healthcare Diagnostics Inc. · Assay, porphyrin, spectrophotometry, lithium2 recalls0 reports
- Atellica CH Li 11097535Siemens Healthcare Diagnostics Inc. · Assay, porphyrin, spectrophotometry, lithium1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 85844).
- Z-2431-2020 · TerminatedAtellica CH Chemistry Calibrator
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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