ADVIA Chemistry Calibrator — Class II medical device recall Z-2430-2020
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-07-01, distributed nationwide. Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrat
| Recall number | Z-2430-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2020-06-05 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2021-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,872 units |
| UPC / GTIN / UDI-DI | 00630414223414 |
| Lot numbers | 534177 |
Product
ADVIA 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2430-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.