Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.

FDA Recall Z-0541-05 · Posted 2005-02-15

Recalling FirmDiamedix Corporation
Recall StatusTerminated
Product CodeLHL
Date Initiated2004-12-23
Date Terminated2012-05-03
Product Quantity178

Reason for Recall

The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.

Firm Action

Direct customers were notified by letter on 12/23/2004 by Federal Express.100% of the total customers will be contacted. The letter instructed the consignees to discontinue use immediately and arrange to return the product to Diamedix.

Root Cause

Other

Distribution Pattern

Distributed to Domestic customers only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970149LEGIONELLA ELISA TEST SYSTEMZeus Scientific, Inc. · 1997-06-18

Official Source

View FDA Recall →

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

↑