Dimension Total Prostate Specific Antigen (TPSA) Flex… recallZ-1606-2008 · Siemens Healthcare Diagnostics Inc. · initiated Mar 24, 2008
Terminated All recalls posted in June 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1606-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 24, 2008
- Posted by the FDA
- Jun 28, 2008
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Quantity
- 1631 cartons
- Product code
- MTF
- FDA submissions
- P000021
- Distribution
- The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE
Product description
Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714
Code information (models, lots, serial numbers)
Lot number GB9021 exp 2009-01-21 and Lot number GB9029 exp 2009-01-29
Other devices under the same FDA submission
2 devices cleared under P000021 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Vista® System TPSA Flex® Reagent Cartridge 10445090Siemens Healthcare Diagnostics Inc. · Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer36 reports
- Dimension® clinical chemistry system TPSA Flex® reagent cartridge 10444889Siemens Healthcare Diagnostics Inc. · Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer12 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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