Recall Z-0873-03 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Dade Behring Inc
Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.
| Date | May 29, 2003 (initiated Apr 21, 2003) |
| Status | Terminated |
| Reason | test results may be inaccurate by 0.2 to 0.5 ng/mL |
| 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 | 662 cartons |
| Distribution | The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.