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

FDA device recall Z-2005-2026 · posted 2026-04-29 · Open, Classified

Recall details

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.

Action taken

On April 2, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: Perform the instructions provided below: " Discontinue use of and discard the kit lots listed in the table above (Products Section). " Please review this letter with your Medical Director/POC Coordinator to determine the appropriate course of action, including for any previously generated results, if applicable. " Complete and return the Field Correction Effectiveness Check Form and Product Replacement Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " For any questions, you may call Siemens Healthineers Technical Solutions Center at 877- 229-3711, available daily from 7:00 AM to 11:00 PM EST.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CHL

Quantity affected

71725 (38025 US, 33700 OUS)

Distribution

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

Date initiated

2026-04-02

Date posted

2026-04-29

Location

Norwood, MA

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