Z-2477-2023Class II

epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

Name: Z-2477-2023 epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Creator: Siemens Healthcare Diagnostics Inc
Published: 2023-06-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-06-01 / Open, Classified

FDA source

Siemens Healthcare Diagnostics Inc began a recall of epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 on 2023-06-01. FDA classified it as Class II and gives the reason as "There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2477-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-01
Posted: 2023-08-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
FDA root cause: Under Investigation by firm
Action: Consignees were notified via an Urgent Medical Device Correction letter beginning June 5, 2023. Consignees were informed of the issue and were provided a workaround and actions to take. The next sensor configuration/software version, sensor configuration 42.1/epoc Host SW v3.38.2 /epoc NXS SW v4.11.11, is available to customers in Siemens Healthineers Document Library or the epoc Live Update Service (eLUS). This next sensor configuration, 42.1, mitigates the issue.
Quantity in commerce: 473 ea
Distribution: US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam
Product codes and lots: UDI-DI: 00809708072254 Siemens Material Number: 10736382 Lots: 03-23002-60 (expiry 19-Jun-2023) and 03-23056-50 (expiry 12-Aug-2023)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2477-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2476-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28
Z-2477-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28
Z-2478-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)