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U.S. Department of Health and Human Services

Class 2 Device Recall epoc BGEM Test Card

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 Class 2 Device Recall epoc BGEM Test Cardsee related information
Date Initiated by FirmJune 01, 2023
Date PostedAugust 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2478-2023
Recall Event ID 92537
510(K)NumberK200107 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Productepoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Code Information UDI-DI: 00630414243788 Siemens Material Number: 10736516 Lots: 04-23043-51 (expiry 30-Jul-2023)
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact
781-269-3000
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionConsignees 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 Commerce348 ea
DistributionUS 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CHL
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