FDA Medical Device Recalls (openFDA)
Dade Behring Inc: Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
- Recall number
- Z-0873-03
- Recalling firm
- Dade Behring Inc
- Product
- Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
- Status
- Terminated
- Initiated
- 2003-04-21
- Posted
- 2003-05-29
- Terminated
- 2003-07-31
- Reason
- test results may be inaccurate by 0.2 to 0.5 ng/mL
- Root cause
- Other
- Action
- 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.
- Quantity
- 662 cartons
- Distribution
- The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.
- Lot, serial or model codes
- Product code number RF451. Lot number CD4085 exp 3/25/04
- 510(k) numbers
- not on file
- PMA numbers
- ["P000021"]
- Product code
- LTJ
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28