ADVIA Centaur CKMB Master Curve Material — Class II medical device recall Z-0115-2019
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-0115-2019 |
|---|---|
| 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 | 379 sets |
| UPC / GTIN / UDI-DI | 00630414056098 |
| Model numbers | 07867768 |
Product
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
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-0115-2019. 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.