FDA Device recall Z-0173-2018
Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US)…
- 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 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US)… 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-0173-2018 |
| 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 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); 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: 6JC001, 6JC001C, 6JC001G (exp. date 2018-01-11); 6MC001, 6MC001C (exp. date 2018-04-29); 6CC001A, 6CC001B,…Lot numbers: 6JC001, 6JC001C, 6JC001G (exp. date 2018-01-11); 6MC001, 6MC001C (exp. date 2018-04-29); 6CC001A, 6CC001B, 6CC001F (exp. date 2017-07-14); 6FC001A, 6FC001C, 6FC001E (exp. 2017-10-27); --- Lot # (UDI): 6CC001A (008427680244436CC001A20170714), 6CC001B (008427680244436CC001B20170714), 6CC001F (008427680244436CC001F20170714), 6FC001A (008427680244436FC001A20171027), 6FC001C (008427680244436FC001C20171027), 6FC001E (008427680244436FC001E20171027), 6JC001 (008427680244436JC00120180111), 6JC001C (008427680244436JC001C20180111), 6JC001G (008427680244436JC001G20180111), 6MC001 (008427680244436MC00120180429), 6MC001C (008427680244436MC001C20180429). |
|---|
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-0173-2018%22
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