FDA Device

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

Hazard

test results may be inaccurate by 0.2 to 0.5 ng/mL

What You Should Do

Remedy

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.

Products

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
UPC
Product code number RF451. Lot number CD4085 exp 3/25/04

Units Affected

662 cartons