Recall Z-1606-2008 ยท MTF Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Siemens Healthcare Diagnostics Inc.
Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714
| Date | Jun 28, 2008 (initiated Mar 24, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 1631 cartons |
| Distribution | The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.