FDA Device recall Z-0174-2018
Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715
- FDA Device
- Class II
- terminated
- Published 2017-12-06
On 2017-12-06 the FDA classified a Class II recall of Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715 by Siemens Healthcare Diagnostics, citing 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 assig….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0174-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-23 |
| Published | 2017-12-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
Reason
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).
Identifiers
| code_info | Lot numbers: 6BQL01, 6BQL01A, 6BQL01B, 6BQL01C, 6BQL01D (exp. date 2017-06-13); 6JQL01A, 6JQL01B, 6JQL01C (exp. date 2…Lot numbers: 6BQL01, 6BQL01A, 6BQL01B, 6BQL01C, 6BQL01D (exp. date 2017-06-13); 6JQL01A, 6JQL01B, 6JQL01C (exp. date 2018-01-31). --- Lot # (UDI): 6BQL01 (008427680063336BQL0120170613), 6BQL01A (008427680063406BQM01A20170617), 6BQL01B (008427680063406BQM01B20170617), 6BQL01C (008427680063406BQM01C20170617), 6BQL01D (008427680063406BQM01D20170617), 6JQL01A (008427680063336JQL01A20180131), 6JQL01B (008427680063336JQL01B20180131), 6JQL01C (008427680063336JQL01C20180131). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0174-2018%22
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