Date Initiated by Firm |
December 18, 2019 |
Date Posted |
January 24, 2020 |
Recall Status1 |
Terminated 3 on June 25, 2020 |
Recall Number |
Z-1230-2020 |
Recall Event ID |
84612 |
510(K)Number |
K070727
|
Product Classification |
Enzymatic method, creatinine - Product Code JFY
|
Product |
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 |
Code Information |
UDI Number: 00630414526690 Lots: All lots |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
|
For Additional Information Contact |
914-631-8000
|
Manufacturer Reason for Recall |
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Siemens Healthcare Diagnostics initiated a customer communication for this issue via letter beginning December 18, 2019. |
Quantity in Commerce |
1,015 units |
Distribution |
US Nationwide |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JFY and Original Applicant = SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
|