Siemens Healthcare Diagnostics, Inc. Recall 92808
Description: ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
Siemens Healthcare Diagnostics, Inc. Recall 92808 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2451-2023 |
| Event ID | 92808 |
| Event Description | ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, and VA. Global distribution. |
| Quantity | 3067 units |
| Recall Reason | There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems. |
| Device Classification | 20230830 |
| Device Code Info | UDI-DI: 00630414279176; Lot Numbers: All lots |
| Center Classification Date | 20230824 |
| Recall Initiation Date | 20230725 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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