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Terminated

Roche Elecsys total PSA CalSet, catalog number 11731696322.

FDA Recall Z-0382-06 · Posted 2006-01-11

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLTJ
Date Initiated2005-12-07
Date Terminated2006-02-26
Product Quantity25,000 kits

Reason for Recall

There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.

Firm Action

Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

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

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