medical Class II Updated 2022-07-20

Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic

Recalled 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

Hazard / Issue

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

Issued by

FDA

Affected States: AL, CA, CO, FL, IA, ID, KS, NM, OK, TX
Lot/Code Info: UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
View official government recall

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