FDA Medical Device Recalls (openFDA)
American Diagnostica, Inc.: 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.
- Recall number
- Z-1426-2010
- Recalling firm
- American Diagnostica, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2010-03-05
- Posted
- 2010-04-21
- Terminated
- 2016-07-29
- Reason
- Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators
- Root cause
- Process control
- Action
- 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.
- Quantity
- 25 kits
- Distribution
- Worldwide distribution: USA and UK, Taiwan and Korea.
- Lot, serial or model codes
- REF 822 lot 102401 CPT Code 85400 expires on 2010NOV24
- 510(k) numbers
- ["K013168"]
- PMA numbers
- not on file
- Product code
- GGP
- Firm FEI
- 1220602
- Firm city
- Stamford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28