Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
FDA device recall Z-0873-03 · posted 2003-05-29 · Terminated
Recall details
- Recalling firm
- Dade Behring Inc
- Reason for recall
- test results may be inaccurate by 0.2 to 0.5 ng/mL
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LTJ
- Quantity affected
- 662 cartons
- Distribution
- The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.
- Date initiated
- 2003-04-21
- Date posted
- 2003-05-29
- Date terminated
- 2003-07-31
- Location
- Newark, DE
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