Dade Behring Inc Rte 896, Glasgow Business Community Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
Brand
Dade Behring Inc Rte 896, Glasgow Business Community
Lot Codes / Batch Numbers
Product code number RF451. Lot number CD4085 exp 3/25/04
Products Sold
Product code number RF451. Lot number CD4085 exp 3/25/04
Dade Behring Inc Rte 896, Glasgow Business Community is recalling Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 ca due to test results may be inaccurate by 0.2 to 0.5 ng/mL. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
test results may be inaccurate by 0.2 to 0.5 ng/mL
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026