Dimension Vista Protein 1 Calibrator — Class II medical device recall Z-0173-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-12-06, distributed nationwide. Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PRO
| Recall number | Z-0173-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2017-05-23 |
| Classified | 2017-11-28 |
| Reported by FDA | 2017-12-06 |
| Terminated | 2018-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, ES, FR, GB, IT, JP, KR, NL, PT, SK |
| Lot numbers | 6CC001A, 6CC001B, 6CC001F, 6FC001A, 6FC001C, 6FC001E, 6JC001, 6JC001C, 6JC001G, 6MC001, 6MC001C |
| Expiration dates | 2017-07-14, 2017-10-27, 2018-01-11, 2018-04-29 |
Product
Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
Reason for recall
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
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-0173-2018. 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.