epoc BUN test cards may show a negative sodium bias
epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.
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: Risk-of-harm product: a measured negative bias in reported sodium results that routine quality control may not detect, with no patient harm reported.
Plain-English summary
The epoc BGEM BUN Test Card, 25 pack, material number 10736515, GTIN 00809708121860, is being recalled. The action covers 37,554 units across the lot numbers listed in the recall notice.
According to Siemens Healthcare Diagnostics Inc., a negative sodium bias may exist in some epoc test card lots, while all other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L, and the maximum bias observed was -14 mmol/L, occurring at a higher sodium concentration around 150 mmol/L. No positive bias has been observed, and the manufacturer states that quality control fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States and to Argentina and Austria among other countries.
Laboratories should identify affected stock using the material number, GTIN and lot numbers above and follow the instructions issued by Siemens.
The recalled product
- Product
- epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Affected units
- 37,554
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 (20)
- Material Number: 10736515. GTIN: 00809708121860. Lot Numbers: 02-25095-30
- 02-25096-30
- 02-25098-30
- 02-25099-30
- 02-25100-30
- 02-25101-30
- 02-25102-30
- 02-25103-30
- 02-25105-30
- 02-25111-30
- 02-25112-30
- 02-25114-30
- 02-25115-30
- 02-25116-30
- 02-25117-30
- 02-25119-30
- 02-25121-30
- 02-25122-30
- 02-25124-30
- 02-25096-40
Distribution
Distributed nationwide across the United States.
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