Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge Product Usage: The TPSA method is an in vit

FDA device recall Z-1540-2012 · posted 2012-05-11 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MTF

Quantity affected

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.

Date initiated

2012-04-02

Date posted

2012-05-11

Date terminated

2013-04-02

Location

Newark, DE