Siemens Healthcare Diagnostics Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Healthcare Diagnostics Inc
Lot Codes / Batch Numbers
UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Products Sold
UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Siemens Healthcare Diagnostics Inc is recalling epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of s due to Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Recommended Action
Per FDA guidance
Siemens has issued an Urgent Medical Device Correction letter POC 22-010.A.US via FedEx beginning on June 1, 2022. An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take: Please dispose any inventory of epoc BGEM test card lot 11-22005-50 currently in your possession in accordance with local and state disposal requirements. You may request free of charge replacement product from your local Siemens or distributor office. Please review your inventory of this product and assess your laboratory s replacement needs. Please use an epoc BGEM test card from another unaffected lot. Review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check and Product Replacement Form attached to this letter. Please retain this letter with your laboratory records and forward it to those who may have received this product. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CO, FL, ID, IA, KS, NM, OK, TX
Page updated: Jan 10, 2026