- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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);
- Units affected
- 71725 (38025 US, 33700 OUS)
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.
- Firm location
- Norwood, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2005-2026
- Recall initiated
- April 2, 2026
- FDA classification date
- April 29, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98680
- Last updated on HTM Vibe
- July 24, 2026