Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714

FDA device recall Z-1606-2008 · posted 2008-06-28 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc.

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.

Action taken

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

Status

Terminated

Product code

MTF

Quantity affected

1631 cartons

Distribution

The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE

Date initiated

2008-03-24

Date posted

2008-06-28

Date terminated

2008-10-15

Location

Newark, DE