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.
FDA Recall Z-0607-2009 · Posted 2009-01-07
Advertisement
Recalling FirmDiamedix Corporation
Recall StatusTerminated
Product CodeLJB
Date Initiated2008-10-10
Date Terminated2010-05-12
Product Quantity974Test Kits
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.
Firm Action
Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.
Root Cause
Other
Distribution Pattern
Worldwide Distribution --- including USA and country of England.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement