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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 Recall
Dimension Vista (R) Enzyme 1 Calibrator (ENZ 1 CAL)
see related information
Date Posted February 24, 2014
Recall Status1 Terminated on May 06, 2015
Recall Number Z-1076-2014
Recall Event ID 67235
Premarket Notification
510(K) Number
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/
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark, Delaware 19702-2466
For Additional Information Contact Customer Support
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) lots 3FD034 and 3HD012.
FDA Determined
Cause 2
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = DADE BEHRING, INC.