Z-2005-2026Class II

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

Name: Z-2005-2026 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515
Creator: Siemens Healthcare Diagnostics Inc
Published: 2026-04-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-04-02 / Open, Classified

FDA source

Siemens Healthcare Diagnostics Inc began a recall of epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515 on 2026-04-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2005-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-02
Posted: 2026-04-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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.
Product codes and lots: 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);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2005-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2005-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code CHL

K200107Class IIepoc Blood Analysis SystemEpocal, Inc. / cleared 2020-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)