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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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