FDA recall Z-1372-2022

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

Reason for recall

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

Distribution

AL CA CO FL IA ID KS NM OK TX

Key facts

Status

Ongoing

Initiation date

2022-06-01

Report date

2022-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norwood, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1372-2022