Date Initiated by Firm |
March 12, 2018 |
Create Date |
May 10, 2018 |
Recall Status1 |
Terminated 3 on June 02, 2020 |
Recall Number |
Z-1799-2018 |
Recall Event ID |
79699 |
510(K)Number |
K102779
|
Product Classification |
Enzyme immunoassay, opiates - Product Code DJG
|
Product |
Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483 |
Code Information |
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 |
Incorrect calibrator level listed in qualitative calibration steps
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Siemens issued an Urgent Medical Device Correction (UMDC) in the U.S. and an Urgent Field Safety Notification (UFSN) in the OUS on 13-March-2018 to notify Syva¿ Emit¿ II Plus 6-Acetylmorphine customers that the calibrator on the Application Sheet is incorrect. |
Distribution |
PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign |
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 = DJG and Original Applicant = Siemens Healthcare Diagnostics Inc.
|