REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantati
FDA device recall Z-1426-2010 · posted 2010-04-21 · Terminated
Recall details
- Recalling firm
- American Diagnostica, Inc.
- Reason for recall
- Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GGP
- Quantity affected
- 25 kits
- Distribution
- Worldwide distribution: USA and UK, Taiwan and Korea.
- Date initiated
- 2010-03-05
- Date posted
- 2010-04-21
- Date terminated
- 2016-07-29
- Location
- Stamford, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMUBIND PLASMA PAI-1 ELISA,MODEL 822 (K013168) | American Diagnostica, Inc. | 2002-03-07 |