—#108560

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

FDA product code: MTF — Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P000021S013
Affected lot / code info: Catalog number: K6451; Mnemonic: TPSA; lot number 11300BB, exp 10/26/2012

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-04-02
Posted by FDA: 2012-05-11
Terminated: 2013-04-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.