Recall Z-1426-2010
American Diagnostica, Inc. · initiated March 5, 2010
Product
REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma.
Codes / lots: REF 822 lot 102401 CPT Code 85400 expires on 2010NOV24
Reason for recall
Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators
FDA-determined cause: Process control
Action taken
Three emails "REF 822 lot 102401 needs to be recalled" dated March 1, 2010 was sent to three customers. The emails described the product, problem and action to be taken by the customers. The customers should send the kit to the firm (SEKISUI american diagnostica inc.) attention of Leigh Ayres, Director, Regulatoy Affairs and Quality Assurance. If you have any question, please call 1-203-602-7777.
Details
- Recall number
- Z-1426-2010
- Initiated
- March 5, 2010
- Posted by FDA
- April 21, 2010
- Terminated
- July 29, 2016
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Quantity
- 25 kits
- Distribution
- Worldwide distribution: USA and UK, Taiwan and Korea.
- Recalling firm
- American Diagnostica, Inc., Stamford, CT