Siemens epoc BGEM Test Card recalled for glucose measurement inaccuracy
Siemens Healthcare Diagnostics is recalling epoc BGEM Test Cards for veterinary use due to potential inaccurate glucose results in lower-range samples. Affected units may report artificially elevated readings.
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: This is a Class II recall affecting a diagnostic device with potential for inaccurate test results (risk-of-harm product). No illnesses, injuries, or deaths have been reported, but the device can produce measurement errors that could affect clinical decision-making. Per the rubric, risk-of-harm products without reported injury score 3.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling certain epoc BGEM Test Card (BUN & TCO2) units used in veterinary diagnostics. The affected test cards are designed to measure blood glucose, BUN (blood urea nitrogen), and TCO2 (total carbon dioxide) in animal samples.
The recall was initiated because of a potential for discrepant high glucose results when testing samples with glucose values on the lower end of the reportable range. This means the test cards may report falsely elevated glucose readings for samples with lower actual glucose levels, potentially leading to inaccurate diagnostic information.
The recall affects 348 test cards distributed across the United States and internationally. Veterinary clinics and laboratories using affected lots should discontinue use and contact the manufacturer for replacement units or product return instructions. Healthcare providers should review recent test results from affected lot numbers to ensure diagnostic accuracy.
The recalled product
- Product
- epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 348
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
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