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Open, Classified

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

FDA Recall Z-2477-2023 · Posted 2023-08-28

Recalling FirmSiemens Healthcare Diagnostics Inc
Recall StatusOpen, Classified
Product CodeCHL
Date Initiated2023-06-01
Product Quantity473 ea

Reason for Recall

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200107epoc Blood Analysis SystemEpocal, Inc. · 2020-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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