ADVIA Centaur CKMB Calibrator — Class II medical device recall Z-0113-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2018-10-24, distributed nationwide. A potential bias was identified with certain kits compared to the internal standards.
| Recall number | Z-0113-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2018-07-24 |
| Classified | 2018-10-15 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2020-05-26 |
| Distributed | Nationwide (US) |
| Quantity | 1,870 kits |
| UPC / GTIN / UDI-DI | 00630414124803 |
| Model numbers | 09318028 |
Product
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Reason for recall
A potential bias was identified with certain kits compared to the internal standards.
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-0113-2019. 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.