Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodi
FDA device recall Z-0607-2009 · posted 2009-01-07 · Terminated
Recall details
- Recalling firm
- Diamedix Corporation
- 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.
- Action taken
- Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJB
- Quantity affected
- 974Test Kits
- Distribution
- Worldwide Distribution --- including USA and country of England.
- Date initiated
- 2008-10-10
- Date posted
- 2009-01-07
- Date terminated
- 2010-05-12
- Location
- Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIAMEDIX IS-MEASLES IGG TEST SYSTEM (K974552) | Diamedix Corp. | 1998-01-28 |