Siemens Healthcare Diagnostics, Inc. Recall: Dimension Vista Protein 1 Control M, PROT 1 C
Siemens Healthcare Diagnostics, Inc. Recall: Dimension Vista Protein 1 Control M, PROT 1 C is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Siemens Healthcare Diagnostics, Inc.; Product: Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product C
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
|---|---|
| Product | Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; 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). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South |
| Recall initiated | 20170523 |
| Recall number | Z-0175-2018 |
| Category | device |
| State | DE |
| Country | United States |
$29/mo
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