Class II — Siemens Healthcare Diagnostics, Inc
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use. |
| Product | ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016. |
| Quantity | 18,733 kits |
| Distribution | Nationwide Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan… |
| Initiated | 2016-10-19 |
| Classified | 2016-11-17 |
| Terminated | 2023-03-02 |
| Recall number | Z-0612-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc (Z-0612-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75523/
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