Z-1540-2012

Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge

Name: Z-1540-2012 Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-04-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-04-02 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2012-04-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1540-2012
Status: Terminated
Initiated: 2012-04-02
Posted: 2012-05-11
Terminated: 2013-04-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Catalog number: K6451; Mnemonic: TPSA; lot number 11300BB, exp 10/26/2012

Product code MTF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)