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Terminated

Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

FDA Recall Z-1072-04 · Posted 2004-07-20

Recalling FirmGen Probe Inc
Recall StatusTerminated
Product CodeNDZ
Date Initiated2004-06-11
Date Terminated2004-09-09

Reason for Recall

Reduced stability

Firm Action

Firm notified all customers by fax and/or overnight letter on June 11, 2004. The notice indicated that users can continue to the MTD product provided that teh Specimen Processing positive cell controls are used according to package insert instructions and valid assay results are obtained. The affected MTD Enzyme Reagent will be replaced with a new lot of reagent.

Root Cause

Other

Official Source

View FDA Recall →

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

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