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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 Open
Recall Number Z-1076-2014
Recall Event ID 67235
Premarket Notification
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, Delaware 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) lots 3FD034 and 3HD012.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 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.
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