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Terminated

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

FDA Recall Z-0873-03 · Posted 2003-05-29

Recalling FirmDade Behring Inc
Recall StatusTerminated
Product CodeLTJ
Date Initiated2003-04-21
Date Terminated2003-07-31
Product Quantity662 cartons

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

The product was shipped to hospitals and clinic laboratories nationwide. There are eight government/military accounts; one of which is foreign.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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