epoc BGEM BUN Test Cards recalled for sodium measurement bias
Siemens recalled epoc BGEM BUN Test Cards for a negative sodium bias occurring approximately 2 months before expiration, with maximum observed bias of -10 mmol/L. No adverse events 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: Class II diagnostic device presenting risk of incorrect test results through measurement bias, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.' No adverse events reported.
Plain-English summary
Siemens Healthcare Diagnostics Inc. has recalled epoc BGEM BUN Test Cards (25-pack) for the epoc Blood Analysis System. Affected lot numbers are 08-24092-60, 08-24093-60, 08-24094-60, 08-24095-60, and 08-24096-60, distributed in the US and Canada.
The test cards may exhibit a negative sodium bias approximately 2 months prior to expiration. Internal testing identified a maximum negative bias of -10 mmol/L, with no positive bias observed. Quality control procedures may not reliably detect the issue, depending on the bias magnitude and frequency of quality control testing. One customer complaint has been associated with this measurement discrepancy.
All affected lot numbers have already expired prior to the recall announcement, and no adverse events have been reported.
The recalled product
- Product
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 1,292
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00809708121860
- Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60
Distribution
Distributed nationwide across the United States.
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