—#201322

Product

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

FDA product code: CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K200107
Affected lot / code info: UDI-DI: 00809708121860 Siemens Material Number: 10736515 Lots: 04-23003-60 (expiry 20-Jun-2023), 11-22337-60 (expiry 20-May-2023), 04-23034-40 (expiry 21-Jul-2023), 04-23059-50 (expiry 15-Aug-2023), 04-23059-60 (expiry 15-Aug-2023), and 04-23069-40 (expiry 25-Aug-2023)

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics Inc
Address: 2 Edgewater Dr, Norwood, Massachusetts 02062-4637

Distribution

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

Timeline

Recall initiated: 2023-06-01
Posted by FDA: 2023-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201322. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.