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.
This recall has been terminated (originally issued January 7, 2009).
- Company
- Diamedix Corporation
- Recall Initiated
- October 10, 2008
- Posted
- January 7, 2009
- Terminated
- May 12, 2010
- Recall Number
- Z-0607-2009
- Quantity
- 974Test Kits
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution --- including USA and country of England.
Lot / Code Info
Lot number 41108 and 41108B
Root Cause
Other
Action Taken
Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.
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