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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge

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  Class 2 Device Recall Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge see related information
Date Initiated by Firm April 02, 2012
Date Posted May 11, 2012
Recall Status1 Terminated 3 on April 02, 2013
Recall Number Z-1540-2012
Recall Event ID 61629
PMA Number P000021S013 
Product Classification Total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer - Product Code MTF
Product Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge

Product Usage:
The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista(R) System
Code Information Catalog number: K6451; Mnemonic: TPSA; lot number 11300BB, exp 10/26/2012
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Robert King
302-631-0516
Manufacturer Reason
for Recall		 Siemens has confirmed a report of leaking Flex(R) reagent cartridge lot 11300BB from Dimension Vista(R) TPSA; when a leaking Flex(R) is used, patient test results may be falsely depressed.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an Urgent Field Safety Notification letter dated April 14, 2012 to all Dimension Vista(R) System customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and discard any remaining inventory of the affected product. Customers were asked to complete the attached form and fax it to 302-631-8467 to indicate that you have received the notification. For technical questions or concerns, contact the Siemens Technical Solutions Center at 800-441-9250.
Quantity in Commerce 1,103 cartons
Distribution USA Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, FL IL, LA, MD, MI, MN, MS, MT, NC, NH, NJ, NV, NY, OH, PA, SD, TN, TX, UT, WI ,WV including Puerto Rico.
Total Product Life Cycle TPLC Device Report
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.
PMA Database PMAs with Product Code = MTF and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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