Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714
FDA Recall Z-1606-2008 · Posted 2008-06-28
Recalling FirmSiemens Healthcare Diagnostics Inc.
Recall StatusTerminated
Product CodeMTF
Date Initiated2008-03-24
Date Terminated2008-10-15
Product Quantity1631 cartons
Reason for Recall
False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.
Firm Action
The recalling firm issued a letter (Urgent Field Safety Notice) dated 3/25/08 to inform their customers to discontinue use of any remaining inventory, retest using an alternate lot for those samples from post-prostatectomy patients which recovered positive TPSA results less than 1.0 ng/nL. The firm has requested that you call the them for no-charge replacement product at 1-800-441-9250 and/or for technical assistance.
Root Cause
Device Design
Distribution Pattern
The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.