Date Initiated by Firm |
August 17, 2022 |
Date Posted |
September 26, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1816-2022 |
Recall Event ID |
90825 |
510(K)Number |
K861700
|
Product Classification |
Photometric method, magnesium - Product Code JGJ
|
Product |
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57 |
Code Information |
Lot Number: UDI
MG lot FA2350 10444963 00842768014185FA235022121610444963840;
MG lot FA2356 10444963 00842768014185FA235622122210444963840;
MG lot GA2363 10444963 00842768014185GA236322122910444963840;
MG lot FA3019 10444963 00842768014185FA301923011910444963840
|
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr Newark DE 19702-2466
|
For Additional Information Contact |
SAME 800-441-9250
|
Manufacturer Reason for Recall |
Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be
produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Siemens Healthineers issued to US Customers Urgent Medical Device Correction (VC-22-01.B.US) on 8/17/22 via Fed'X and OUS Customers sent Urgent Field Safety Notice (VC-22-01.B.OUS) to inform them to discontinue use and discard Dimension MG lots FA2350, FA2356, GA2363, and FA3019. Letter states reason for recall, health risk and action t take:
Discontinue use and discard Dimension MG lots listed in Table 1.
Review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities.
Please review this letter with your Medical Director.
Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.
If you received any complaints of illness or adverse events associated with the products
listed in Table 1, immediately contact your local Siemens Remote Services Center or your
local Siemens Technical Support Representative.
Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers
technical support representative |
Quantity in Commerce |
26851 units |
Distribution |
Nationwided
Foreign:
Afghanistan¿¿¿¿
Albania¿¿¿¿¿¿¿¿
Austria¿¿¿¿¿¿¿¿
Bahrain¿¿¿¿¿¿¿¿
Bosnia¿Herzeg.¿
Bulgaria¿¿¿¿¿¿¿
Canada
Croatia¿¿¿¿¿¿¿¿
Czech¿Republic¿
Egypt¿¿¿¿¿¿¿¿¿¿
France¿¿¿¿¿¿¿¿¿
Georgia¿¿¿¿¿¿¿¿
Germany¿¿¿¿¿¿¿¿
Greece¿¿¿¿¿¿¿¿¿
Hungary¿¿¿¿¿¿¿¿
Israel¿¿¿¿¿¿¿¿¿
Italy¿¿¿¿¿¿¿¿¿¿
Jordan¿¿¿¿¿¿¿¿¿
Kazakhstan¿¿¿¿¿
Kenya¿¿¿¿¿¿¿¿¿¿
Kuwait¿¿¿¿¿¿¿¿¿
Latvia¿¿¿¿¿¿¿¿¿
Lebanon¿¿¿¿¿¿¿¿
Macedonia¿¿¿¿¿¿
Mali¿¿¿¿¿¿¿¿¿¿¿
Malta¿¿¿¿¿¿¿¿¿¿
Montenegro¿¿¿¿¿
Morocco¿¿¿¿¿¿¿¿
Nepal¿¿¿¿¿¿¿¿¿¿
Netherlands¿¿¿¿
Pakistan¿¿¿¿¿¿¿
Poland¿¿¿¿¿¿¿¿¿
Portugal¿¿¿¿¿¿¿
Qatar¿¿¿¿¿¿¿¿¿¿
Romania¿¿¿¿¿¿¿¿
Russian¿Fed.¿¿¿
Saudi¿Arabia¿¿¿
Senegal¿¿¿¿¿¿¿¿
Serbia¿¿¿¿¿¿¿¿¿
Slovakia¿¿¿¿¿¿¿
Slovenia¿¿¿¿¿¿¿
Spain¿¿¿¿¿¿¿¿¿¿
Sudan¿¿¿¿¿¿¿¿¿¿
Switzerland¿¿¿¿
Turkey¿¿¿¿¿¿¿¿¿
U.A.E.¿¿¿¿¿¿¿¿¿
Uganda¿¿¿¿¿¿¿¿¿
Ukraine¿¿¿¿¿¿¿¿
United¿Kingdom¿
Uzbekistan¿¿¿¿¿
|
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 = JGJ and Original Applicant = E.I. DUPONT DE NEMOURS & CO., INC.
|