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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 FirmMarch 12, 2018
Create DateMay 10, 2018
Recall Status1 Terminated 3 on June 02, 2020
Recall NumberZ-1800-2018
Recall Event ID 79699
510(K)NumberK102779 
Product Classification Enzyme immunoassay, opiates - Product Code DJG
ProductSyva 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
ActionSiemens 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.
DistributionPA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DJG
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