Dimension TSPA (Total Prostate Specific Antigen) Flex… recallZ-0873-03 · Dade Behring Inc · initiated Apr 21, 2003
Terminated All recalls posted in May 2003
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 Dade Behring 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
test results may be inaccurate by 0.2 to 0.5 ng/mL
FDA root cause category: Other
What the company is doing
The recalling firm telephone each customer on 4/24-28/03 to determine if any customer used the lot (CD4085). If so, the customer was instructed to retest all samples with an alternate lot. All customers were instructed to discard any remaining inventory. As a follow up to the phone calls, the recalling firm issued a recall letter dated 4/25/03 informing the customer of the problem and to discard any remaining product.
Recall details
- Recall number
- Z-0873-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 21, 2003
- Posted by the FDA
- May 29, 2003
- Recalling firm
- Dade Behring Inc
- Quantity
- 662 cartons
- Product code
- LTJ
- FDA submissions
- P000021
- Distribution
- The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.
Product description
Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
Code information (models, lots, serial numbers)
Product code number RF451. Lot number CD4085 exp 3/25/04
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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