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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 Recall
Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge
see related information
Date Posted May 11, 2012
Recall Status1 Terminated on April 02, 2013
Recall Number Z-1540-2012
Recall Event ID 61629
Premarket Approval
PMA Number
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/
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101
For Additional Information Contact Robert King
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
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 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.
PMA Database PMAs with Product Code = MTF and Applicant = SIEMENS HEALTHCARE DIAGNOSTICS INC.