FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
- Recall number
- Z-2970-2020
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#/Model #: 10736382
- Status
- Terminated
- Initiated
- 2020-08-28
- Posted
- not on file
- Terminated
- 2021-09-09
- Reason
- Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.
- Root cause
- Process control
- Action
- Siemens issued Urgent Medical Device Correction letter on August 28, 2020 via Federal Express stating the reason for recall communication letter informs customers of the issue and, health risk and action take: Please dispose any inventory of test card lot 01-20095-10 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 these products and assess your laboratorys replacement needs. Please use epoc BGEM Test Card from another unaffected lot. 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, please contact your Siemens Customer Care Center or your local Siemens technical support representative.
- Quantity
- 463 boxes (50 test cards/box )
- Distribution
- Nationwide Foreign: Canada
- Lot, serial or model codes
- Lot Number: 01-20095-10
- 510(k) numbers
- ["K200107"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28