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Siemens Healthcare Diagnostics, Inc. Recall 88784

Description: Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

Siemens Healthcare Diagnostics, Inc. Recall 88784 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0181-2022
Event ID88784
Event DescriptionAdvia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution.
Quantity246 (US); 689 (OUS)
Recall ReasonThe firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Device Classification20211103
Device Code InfoAll lots impacted
Center Classification Date20211028
Recall Initiation Date20210920
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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