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Terminated

Immulite 2500 insulin Kit

FDA Recall Z-0324-05 · Posted 2004-12-17

Recalling FirmDiagnostic Products Corp
Recall StatusTerminated
Product CodeCFP
Date Initiated2004-11-19
Date Terminated2005-03-24
Product Quantity10 kits

Reason for Recall

Low bias of 10 to 40% at different levels of insulin in samples.

Firm Action

Customers were notified by telephone on 11/19/2004. They were instructed to discard remaining kits.

Root Cause

Other

Distribution Pattern

Medical facilities in AK, NY, WI.

Official Source

View FDA Recall →

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

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