Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
This recall has been terminated (originally issued May 29, 2003).
- Recall Initiated
- April 21, 2003
- Posted
- May 29, 2003
- Terminated
- July 31, 2003
- Recall Number
- Z-0873-03
- Quantity
- 662 cartons
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
test results may be inaccurate by 0.2 to 0.5 ng/mL
Distribution
The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.
Lot / Code Info
Product code number RF451. Lot number CD4085 exp 3/25/04
Root Cause
Other
Action Taken
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.