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Siemens Healthcare Diagnostics Inc Recall 90432

Description: epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515

Siemens Healthcare Diagnostics Inc Recall 90432 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1372-2022
Event ID90432
Event Descriptionepoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515
Product TypeDevices
DistributionAL CA CO FL IA ID KS NM OK TX
Quantity263 Boxes
Recall ReasonDiscrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Device Classification20220720
Device Code InfoUDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Center Classification Date20220712
Recall Initiation Date20220601
Recalling FirmSiemens Healthcare Diagnostics Inc
Initial Notification Letter
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