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

Company / brand

Siemens Healthcare Diagnostics Inc

Product

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

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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

Recall initiated

2026-04-02

Code info

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);

Product quantity

71725 (38025 US, 33700 OUS)

Voluntary mandated

Voluntary: Firm initiated

City

Norwood

State

MA

Country

United States

Event id

98680

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