| Class 2 Device Recall Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Reagent Cartridge (K4071) | |
Date Initiated by Firm | August 09, 2012 |
Date Posted | November 20, 2012 |
Recall Status1 |
Terminated 3 on January 08, 2014 |
Recall Number | Z-0408-2013 |
Recall Event ID |
62835 |
510(K)Number | K062024 |
Product Classification |
Enzyme immunoassay theophylline - Product Code KLS
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Product | Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071)
The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system. |
Code Information |
Lots 12135AE and 12171BB |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, Mailstop 514 PO BOX 6101 Newark DE 19714-6101
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For Additional Information Contact | 302-631-6311 |
Manufacturer Reason for Recall | Firm has received complaints from customers of "Abnormal Reaction" errors occurring on calibrations, QC and patient samples. The Abnormal Reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Siemens Healthcare Diagnostic sent a Urgent Field Safety notice dated July, 20. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please immediately discontinue use and discard any remaining inventory of Dimension Vista Theophylline Flex reagent cartridge (THEO, Catalog # K4071) lot 12135AE and/or 12171BB.
Please complete the attached form and fax it to (302)631-8467 to indicate that you have received this information and to facilitate your additional no charge replacement.
We ask that you forward this notification to anyone to whom you may have distributed this lot.
If you have technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance. For questions concerning the status of your no charge replacement order please contact your Siemens Customer Service Center at 888-588-3916.
We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support. |
Quantity in Commerce | 959 cartons |
Distribution | USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KLS
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