Z-0607-2009

Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human...

Name: Z-0607-2009 Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human...
Creator: Diamedix Corporation
Published: 2008-10-10
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2008-10-10 / Terminated

FDA source

Diamedix Corporation began a recall of Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by... on 2008-10-10. The reason FDA records is "Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0607-2009
Status: Terminated
Initiated: 2008-10-10
Posted: 2009-01-07
Terminated: 2010-05-12
Recalling firm: Diamedix Corp.
Product: Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.
Product code: LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Reason for recall: Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus sensing of and picking up of samples. As a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.
FDA root cause: Other
Action: Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.
Quantity in commerce: 974Test Kits
Distribution: Worldwide Distribution --- including USA and country of England.
Product codes and lots: Lot number 41108 and 41108B

Product code LJB

K974552Class IDiamedix Is-Measles Igg Test SystemDiamedix Corp. / cleared 1998-01-28

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)