Z-0286-2025Class II

epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

Name: Z-0286-2025 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Creator: Siemens Healthcare Diagnostics Inc
Published: 2024-09-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-09-24 / 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, SMN 10736515 on 2024-09-24. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0286-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-24
Posted: 2024-11-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Correction letter dated September 2024 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " If you are a distributor, please ensure your customers receive this UMDC letter. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of the affected products listed in the above table 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.
Quantity in commerce: 1292 units
Distribution: US Nationwide. Canada.
Product codes and lots: UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0286-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0286-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-01

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)