epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic… recallZ-1372-2022 · Siemens Healthcare Diagnostics Inc · initiated Jun 1, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1372-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 1, 2022
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Quantity
- 263 Boxes
- Product code
- CHL
- FDA submissions
- K192240
- Distribution
- AL CA CO FL IA ID KS NM OK TX
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
Code information (models, lots, serial numbers)
UDI-DI: 00809708121860 Lot Number: 11-22005-50 Exp. Date: 22-June-2022
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EPOC BGEM BUN TEST CARD 10736515Epocal Inc6 recalls1 report
Other devices under the same FDA submission
1 device cleared under K192240 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- RAPIDPoint® 500e Blood Gas System 11416751Siemens Healthcare Diagnostics Inc. · ELECTRODE, ION SPECIFIC, CALCIUM2 recalls7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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