FDA Device recall Z-0175-2018
Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716
- 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 M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716 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-0175-2018 |
| 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 M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; 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: 6BQM01, 6BQM01A, 6BQM01B, 6BQM01C,6BQM01D, 6BQM01E (exp. date 2017-06-17); 6FQM01, 6FQM01A (exp. date 201…Lot numbers: 6BQM01, 6BQM01A, 6BQM01B, 6BQM01C,6BQM01D, 6BQM01E (exp. date 2017-06-17); 6FQM01, 6FQM01A (exp. date 2017-11-03) --- Lot # (UDI): 6BQM01 (008427680063336JQL01C20180131), 6BQM01A (008427680063406BQM01A20170617), 6BQM01B (008427680063406BQM01B20170617), 6BQM01C (008427680063406BQM01C20170617), 6BQM01D( 008427680063406BQM01D20170617), 6BQM01E (008427680063406BQM01E20170617), 6FQM01(008427680063406FQM0120171103), 6FQM01A (008427680063406FQM01A20171103). |
|---|
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-0175-2018%22
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