FDAClass II · Medical device · Recalled May 6, 2026

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System recall — Siemens Healthcare Diagnostics Inc

Hazard: Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2005-2026
Brand: Siemens Healthcare Diagnostics
Classification: Class II
Units affected: 71725 (38025 US, 33700 OUS)
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

Affected products

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System

Companies & origin

Recalling firm location: Norwood, MA, United States
Firm address: 2 Edgewater Dr, 02062-4637

Identifying details (verbatim from the notice)

Product codes / lots: Siemens Material Number (SMN): 10736515; UDI-DI: 00809708121860; Lot numbers: 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70 (OUS only), 02-26027-80, 02-26028-80 (OUS only);
Distribution: Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.
Firm notified the public via: Letter
FDA event ID: 98680
Recall initiated: April 2, 2026
FDA classified: April 29, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 1:09 AM UTC.

Report a data error on this page