epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

FDA device recall Z-2272-2025 · posted 2025-08-05 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc

Reason for recall

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.

Action taken

Siemens Healthcare Diagnostics notified consignees via letter on about 07/07/2025. Consignees were instructed to review the letter with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, discard and request a replacement of any affected lots or if your institution does not need to report sodium, you can turn off sodium following the instruction of the owner s manual. Consignees were also instructed to complete and return the Field Correction Effectiveness Check Form included with letter, notify customers if products were further distributed, and to retain this letter with your laboratory records and forward this letter to those who may have received this product at your site.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JGS

Quantity affected

37,554 units

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bahrain, Bolivia, Brazil, Canada, Canary Islands, Chile, Croatia, Denmark, Ecuador, Estonia, France, Fren. Polynesia, Ge

Date initiated

2025-07-07

Date posted

2025-08-05

Location

Norwood, MA

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