Z-0873-03

Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges...

Name: Z-0873-03 Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges...
Creator: Dade Behring Inc
Published: 2003-04-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-04-21 / Terminated

FDA source

Dade Behring Inc began a recall of Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton on 2003-04-21. The reason FDA records is "test results may be inaccurate by 0.2 to 0.5 ng/mL". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0873-03
Status: Terminated
Initiated: 2003-04-21
Posted: 2003-05-29
Terminated: 2003-07-31
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
Product code: LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Reason for recall: test results may be inaccurate by 0.2 to 0.5 ng/mL
FDA 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 in commerce: 662 cartons
Distribution: The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.
Product codes and lots: Product code number RF451. Lot number CD4085 exp 3/25/04

Product code LTJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)