| Class 2 Device Recall epoc BGEM Test Card | |
Date Initiated by Firm | June 01, 2023 |
Date Posted | August 28, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2476-2023 |
Recall Event ID |
92537 |
510(K)Number | K200107 |
Product Classification |
Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
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Product | epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1 |
Code Information |
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) |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics Inc 2 Edgewater Dr Norwood MA 02062-4637
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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 |
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 | 3201 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 |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = CHL
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