epoc BGEM BUN Test Cards for Blood Analysis System Recalled
Siemens Healthcare Diagnostics is recalling epoc BGEM BUN Test Cards (25 pk) due to discrepant high pH results when samples are introduced with higher injection volumes on affected sensor configurations.
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 an FDA Class II recall involving a diagnostic device with a risk of inaccurate results (high pH readings). The source text does not report any actual illnesses or injuries, but the hazard is a malfunctioning medical diagnostic, which poses a risk of harm through incorrect test results.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling epoc BGEM BUN Test Cards (25 pk), Material Number 10736515, used with the epoc Blood Analysis System. The recall affects units with specific software versions (epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11) and Sensor Configuration 45.n.
The recalled test cards can produce discrepant high pH results when samples are introduced with higher injection volumes. This issue affects lot numbers with the prefix 02 or 12.
The affected test cards have been distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, United Kingdom, Germany, France, Japan, and others. A total of 264,252 units have been distributed.
Customers using the affected test cards should review their results for samples with higher injection volumes and contact Siemens Healthcare Diagnostics Inc if they have questions about potentially affected units.
The recalled product
- Product
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 264,252
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 (6)
- Siemens Material Number (SMN): 10736515
- Udi-DI: 00809708121860
- Lot Numbers: All lot numbers with prefix (xx) 02 or 12
- epoc Software Version and Senor Configuration: epoc Host SW V3.41.2
- epoc NXS SW v4.14.9 & 4.14.11
- Sensor Configuration 45.n.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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