Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card

Recalling company

Siemens Healthcare Diagnostics Inc

Product

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Apr 2, 2026

Reported

May 6, 2026

Distribution

Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.

Status

Ongoing

Quantity

71725 (38025 US, 33700 OUS)

Lot / codes

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);

Company location

Norwood, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2005-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2005-2026 in the FDA Enforcement Report. Also see FDA recall press releases.