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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2451-2023
Event ID92808
Event DescriptionADVIA 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 TypeDevices
DistributionWorldwide - 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.
Quantity3067 units
Recall ReasonThere 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 Classification20230830
Device Code InfoUDI-DI: 00630414279176; Lot Numbers: All lots
Center Classification Date20230824
Recall Initiation Date20230725
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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