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U.S. Department of Health and Human Services

Class 2 Device Recall epoc BGEM BUN Test Card

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 Class 2 Device Recall epoc BGEM BUN Test Cardsee related information
Date Initiated by FirmSeptember 24, 2024
Date PostedNovember 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0286-2025
Recall Event ID 95504
510(K)NumberK200107 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Productepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Code Information UDI-DI: 00809708121860; Lot Numbers: 08-24092-60 08-24093-60 08-24094-60 08-24095-60 08-24096-60
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information ContactCustomer Service
877-229-3711
Manufacturer Reason
for Recall		Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn Urgent Medical Device Correction letter dated September 2024 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " If you are a distributor, please ensure your customers receive this UMDC letter. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of the affected products listed in the above table may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " For any questions, you may call Siemens Healthineers Technical Solutions Center at 877-229-3711.
Quantity in Commerce1292 units
DistributionUS Nationwide. Canada.
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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