Z-0541-05

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

Name: Z-0541-05 The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured...
Creator: Diamedix Corporation
Published: 2004-12-23
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2004-12-23 / Terminated / root cause: manufacturing process

FDA source

Diamedix Corporation began a recall of The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert on 2004-12-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0541-05
Status: Terminated
Initiated: 2004-12-23
Posted: 2005-02-15
Terminated: 2012-05-03
Recalling firm: Diamedix Corp.
Product: The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
Product code: LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
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.
Root cause tag: manufacturing process
FDA root cause: Other
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.
Quantity in commerce: 178
Distribution: Distributed to Domestic customers only.
Product codes and lots: Lot # 91803Z and 30804/30804Z

Product code LHL

K970149Class IILegionella Elisa Test SystemZeus Scientific, Inc. / cleared 1997-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)