FDA Recalls Siemens epoc BGEM Crea Test Cards for Inaccurate Glucose Results
Siemens Healthcare is recalling epoc BGEM Crea Test Cards that may produce inaccurate glucose readings in lower-range samples. 473 units were distributed to US facilities and international locations. No injuries reported.
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: FDA Class II recall for a diagnostic medical device with potential to report inaccurate test results that could affect patient care. No illnesses or injuries reported; hazard is theoretical but meets 'risk-of-harm products' criterion.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling epoc BGEM Crea Test Cards with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, and Sensor Configuration 41.1. The recall affects 473 units distributed in the United States and internationally.
The test cards may produce discrepant (inaccurate) high glucose results in samples with glucose levels at the lower end of the reportable range. This could result in patients' glucose values being misread, potentially leading to incorrect clinical decisions. No illnesses, injuries, or confirmed patient harm have been reported.
Healthcare providers and laboratories in affected locations should immediately stop using the affected lot numbers (03-23002-60 with expiry June 19, 2023, and 03-23056-50 with expiry August 12, 2023) and contact Siemens Healthcare Diagnostics for guidance on replacement units.
The recalled product
- Product
- epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 473
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics Inc
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06