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Recall Observatory FDA recall evidence

Device product

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

Z-1372-2022

June 01, 2022

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 90432
Status
Ongoing
Classification
Class II
Quantity
263 Boxes
Official record key
device-enforcement:Z-1372-2022

Official wording

Reason: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

Code information: UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022

Distribution pattern: AL CA CO FL IA ID KS NM OK TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.