Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall EPOC BGEM BUN TEST CARD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall EPOC BGEM BUN TEST CARDsee related information
Date Initiated by FirmApril 02, 2026
Date PostedApril 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2005-2026
Recall Event ID 98680
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; Siemens Material Number (SMN): 10736515;
Code Information Siemens Material Number (SMN): 10736515; UDI-DI: 00809708121860; Lot numbers: 01-26024-70, 01-26026-70, 01-26028-70, 01-26030-70 (OUS only), 02-26027-80, 02-26028-80 (OUS only);
FEI Number 3002637618
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information ContactCustomer Service USA
877-229-3711
Manufacturer Reason
for Recall		Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn April 2, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: Perform the instructions provided below: " Discontinue use of and discard the kit lots listed in the table above (Products Section). " Please review this letter with your Medical Director/POC Coordinator to determine the appropriate course of action, including for any previously generated results, if applicable. " Complete and return the Field Correction Effectiveness Check Form and Product Replacement Form attached to this letter within 30 days. " Adverse reactions or quality problems experienced with the use of this product 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, available daily from 7:00 AM to 11:00 PM EST.
Quantity in Commerce71725 (38025 US, 33700 OUS)
DistributionWorldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.
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
-
-