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
Reported: July 20, 2022 Initiated: June 1, 2022 #Z-1372-2022
Product 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
Reason for Recall
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Units Affected
- 263 Boxes
- Distribution
- AL CA CO FL IA ID KS NM OK TX
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 263 Boxes.
Why was this product recalled? ▼
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1372-2022.
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