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 Siemens Healthcare Diagnostics, Inc.

  • 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 Siemens Healthcare Diagnostics, Inc. see related information
Date Initiated by Firm June 01, 2022
Create Date July 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-1372-2022
Recall Event ID 90432
510(K)Number K192240  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood
Product Siemens SMN#/Model #: 10736515
Code Information UDI-DI: 00809708121860 Lot Number: 11-22005-50  Exp. Date: 22-June-2022
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact SAME
781-269-3000
Manufacturer Reason
for Recall		 Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens has issued an Urgent Medical Device Correction letter POC 22-010.A.US via FedEx beginning on June 1, 2022. An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities. Letter states reason for recall, health risk and action to take: Please dispose any inventory of epoc BGEM test card lot 11-22005-50 currently in your possession in accordance with local and state disposal requirements. You may request free of charge replacement product from your local Siemens or distributor office. Please review your inventory of this product and assess your laboratory s replacement needs. ¿ Please use an epoc BGEM test card from another unaffected lot. ¿ Review this letter with your Medical Director. ¿ Complete and return the Field Correction Effectiveness Check and Product Replacement Form attached to this letter. Please retain this letter with your laboratory records and forward it to those who may have received this product. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in Commerce 263 Boxes
Distribution AL CA CO FL IA ID KS NM OK TX
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CHL and Original Applicant = Siemens Healthcare Diagnostics, Inc.
-
-