Atellica CH Chemistry Calibrator recallZ-2431-2020 · 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-2431-2020
- Status
- Terminated
- Initiated by the company
- Jun 5, 2020
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1522 units
- Product code
- CGX
- FDA submissions
- K161494
- Distribution
- US Nationwide Distribution
Product description
Atellica CH Chemistry Calibrator
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atellica CH CHEM Calibrator 11099411Siemens Healthcare Diagnostics Inc. · Calibrator, secondary1 recall2 reports
Other devices under the same FDA submission
1 device cleared under K161494 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Atellica CH Crea_2 11097596Siemens Healthcare Diagnostics Inc. · ALKALINE PICRATE, COLORIMETRY, CREATININE19 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 85844).
- Z-2430-2020 · TerminatedADVIA 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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