FDA Device recall Z-2272-2025
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of epoc BGEM BUN Test Card [25pk]. Material Number: 10736515 by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed av….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2272-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-07 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Reason
Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
Identifiers
| code_info | Material Number: 10736515. GTIN: 00809708121860. Lot Numbers: 02-25095-30, 02-25096-30, 02-25098-30, 02-25099-30, 02-25…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, 02-25097-40, 02-25098-40, 02-25099-40, 02-25101-40, 02-25102-40, 02-25105-40, 02-25106-40, 02-25121-40, 02-25122-40, 02-25124-40, 02-25125-40, 02-25096-50, 02-25098-50, 02-25099-50, 02-25100-50, 02-25102-50, 02-25103-50, 02-25105-50, 02-25107-50, 02-25108-50, 02-25111-50, 02-25112-50, 02-25113-50, 02-25114-50, 02-25115-50, 02-25119-50, 02-25120-50, 12-25096-60, 12-25097-60, 12-25098-60, 12-25100-60, 12-25101-60, 12-25102-60, 12-25103-60, 12-25111-60, 02-25112-60, 02-25113-60, 02-25114-60, 02-25115-60, 02-25116-60, 02-25117-60, 02-25118-60, 02-25120-60, 02-25121-60, 02-25122-60, 02-25123-60, 02-25124-60, 02-25099-70, 02-25101-70, 02-25104-70, 02-25105-70, 02-25107-70, 02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Siemens Healthcare Diagnostics
- Atellica CH Revised C-Reactive Protein (RCRP)
FDA Device · Class II · 2026-10-07 · Siemens Healthcare Diagnostics - Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics - Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
FDA Device · Class II · 2026-08-26 · Siemens Healthcare Diagnostics - Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
FDA Device · Class III · 2026-08-12 · Siemens Healthcare Diagnostics - Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
FDA Device · Class II · 2026-08-12 · Siemens Healthcare Diagnostics
All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2272-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.