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.
|