Recall Z-1372-2022— Siemens Healthcare Diagnostics Inc
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2022-06-01. It names one FDA 510(k) clearance: K192240. 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: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support..
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-01
- Firm location
- Norwood, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.