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U.S. Department of Health and Human Services

Class 3 Device Recall Dimension Enzyme II calibrator

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  Class 3 Device Recall Dimension Enzyme II calibrator see related information
Date Initiated by Firm May 05, 2016
Create Date February 16, 2017
Recall Status1 Terminated 3 on February 02, 2018
Recall Number Z-1217-2017
Recall Event ID 76293
510(K)Number K103836  
Product Classification Calibrator, secondary - Product Code JIT
Product The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.
Code Information Product Lot: 4MD047, 5CD052, 5FD017, 5GD050, 5HD010, 5JD069, 5LD051, 6AD054
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue. For further questions, please call (800) 441-9250.
Quantity in Commerce 24,940.00
Distribution Distributed throughout the United States
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 = JIT and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS INC
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