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U.S. Department of Health and Human Services

Class 3 Device Recall Syva EMIT II Plus 6Acetylmorphine (Application Sheet for the Dimension EXLTM 200,

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  Class 3 Device Recall Syva EMIT II Plus 6Acetylmorphine (Application Sheet for the Dimension EXLTM 200, see related information
Date Initiated by Firm March 12, 2018
Create Date May 10, 2018
Recall Status1 Terminated 3 on June 02, 2020
Recall Number Z-1800-2018
Recall Event ID 79699
510(K)Number K102779  
Product Classification Enzyme immunoassay, opiates - Product Code DJG
Product Syva¿ EMIT¿ II Plus 6-Acetyl morphine
Catalog # for 28 mL: 9R039UL /SMN# 10470440
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.
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