Recall Z-0607-2009 ยท LJB Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Diamedix Corporation
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.
| Date | Jan 7, 2009 (initiated Oct 10, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express. |
| Quantity | 974Test Kits |
| Distribution | Worldwide Distribution --- including USA and country of England. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM Diamedix Corp., Jan 28, 1998 |