Z-2005-2026 Class II Ongoing
FDA device recall Z-2005-2026 was initiated by Siemens Healthcare Diagnostics Inc on April 2, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 71725 (38025 US, 33700 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2026
- Initiation Date
- April 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71725 (38025 US, 33700 OUS)
Product Description
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.
Code Information
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);