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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista (R) Enzyme 1 Calibrator (ENZ 1 CAL)

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  Class 2 Device Recall Dimension Vista (R) Enzyme 1 Calibrator (ENZ 1 CAL) see related information
Date Initiated by Firm January 06, 2014
Date Posted February 24, 2014
Recall Status1 Terminated 3 on May 06, 2015
Recall Number Z-1076-2014
Recall Event ID 67235
510(K)Number K061923  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012.

An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
Code Information lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Customer Support
800-441-9250
Manufacturer Reason
for Recall		 Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A recall notification letter, dated January 2014, was sent to Users.
Quantity in Commerce 3496
Distribution Nationwide Distribution.
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 = JIX and Original Applicant = DADE BEHRING, INC.
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