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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista LOCI Reaction Vessel

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 Class 2 Recall
Dimension Vista LOCI Reaction Vessel
see related information
Date Posted March 05, 2010
Recall Status1 Terminated on September 08, 2011
Recall Number Z-0980-2010
Recall Event ID 54039
Premarket Notification
510(K) Number
K051087 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Dimension Vista LOCI Reaction Vessel
Code Information Catalog number KS855. Lot number NH29-188-09
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
For Additional Information Contact Siemens Technical Solutions Center
800-441-9250
Manufacturer Reason
for Recall
Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The recalling firm issued an Urgent Field Safety Notice dated 11/2009 to all affected customers. Customers have been told to discard any bags of the affected lot. If the affected lot is the only lot the customer has, customers can examine a vessel from the bag. If the vessel mold cavity identity is B8, customers should discard the bag. Thus customers can use the lot if the cavity mold is anything other than B8. In addition, customers have been told to empty the LOCI vessel holder on all systems and to discard vessels in case any affected vessels have been loaded onto the system. For technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
Quantity in Commerce 408 units
Distribution The device was shipped to medical facilities in CA, CO, FL, GA, IL, LA, MD, MI, MS, NE, NC, NJ, NY, OH, SC, TN, TX, VA, WA, and WI. The product was also shipped to Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, and Switzerland.
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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