Recall Z-0176-2018— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-05-23, terminated 2018-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; 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)..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-23
- Terminated
- 2018-03-30
- Firm location
- Newark, DE, United States
Product description
Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; 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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.