Blood gas test device recalled for inaccurate oxygen measurements
Siemens epoc BGEM Test Cards may produce inaccurate blood oxygen measurements, potentially leading to misdiagnosis and unnecessary respiratory treatment. The recall affects 263 boxes distributed across multiple states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves risk of diagnostic error and unnecessary treatment initiation, but no reported illnesses or injuries have been documented. Per the rubric, risk-of-harm medical devices without reported harm are scored as High (3).
Plain-English summary
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards (25-card boxes, model 10736515) due to inaccurate blood oxygen (pO2) measurement results. The affected lot (11-22005-50, expiring June 22, 2022) comprises 263 boxes distributed to healthcare facilities in Alabama, California, Colorado, Florida, Iowa, Idaho, Kansas, New Mexico, Oklahoma, and Texas.
The test cards may produce discrepant low-bias pO2 results, meaning they can underestimate blood oxygen levels. This inaccuracy could lead to misdiagnosis of low blood oxygen (hypoxemia) and inappropriate initiation of respiratory support in patients who do not need it.
Healthcare providers using epoc BGEM Test Cards from this lot should discontinue use immediately. Patients who may have received testing with these cards should consult their healthcare provider. Contact Siemens Healthcare Diagnostics for guidance on replacement supplies.
No illnesses or injuries from this defect have been reported to the FDA at this time.
The recalled product
- 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
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- diagnostic-error
- misdiagnosis
- unnecessary-treatment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Distribution
Distributed in 10 states:
- AL
- CA
- CO
- FL
- IA
- ID
- KS
- NM
- OK
- TX
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