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U.S. Department of Health and Human Services

Class 3 Device Recall Dimension Vista LOCI Reaction Vessels

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 Class 3 Recall
Dimension Vista LOCI Reaction Vessels
see related information
Date Posted August 02, 2010
Recall Status1 Terminated on August 03, 2010
Recall Number Z-2117-2010
Recall Event ID 55226
Premarket Notification
510(K) Number
K051087 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.
Code Information Lot numbers NH20-309-09, NH20-330-09, NH20-337-09, and NH20-001-10
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
For Additional Information Contact Technical Solutions Center
800-441-9250
Manufacturer Reason
for Recall
Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin.
FDA Determined
Cause 2
DESIGN: Process Design
Action Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated March 2010 informing users of the potential problem, to discard any remaining product, and if needed, to request a replacement lot.
Quantity in Commerce 5544 bags
Distribution Worldwide distribution: USA, Canada, Europe, Japan, Korea, and New Zealand.
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 = JJE and Original Applicant = DADE BEHRING, INC.
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