Z-1426-2010

REF 822 IMUBIND(R) Plasma PAI-1 ELISA The

Name: Z-1426-2010 REF 822 IMUBIND(R) Plasma PAI-1 ELISA The
Creator: American Diagnostica, Inc.
Published: 2010-03-05
License: https://open.fda.gov/license/

Sekisui Diagnostics, LLC / initiated 2010-03-05 / Terminated / root cause: manufacturing process

FDA source

American Diagnostica, Inc. began a recall of 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... on 2010-03-05. The reason FDA records is "Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1426-2010
Status: Terminated
Initiated: 2010-03-05
Posted: 2010-04-21
Terminated: 2016-07-29
Recalling firm: Sekisui Diagnostics, LLC
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.
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
Reason for recall: Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators
Root cause tag: manufacturing process
FDA 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 in commerce: 25 kits
Distribution: Worldwide distribution: USA and UK, Taiwan and Korea.
Product codes and lots: REF 822 lot 102401 CPT Code 85400 expires on 2010NOV24

Product code GGP

K013168Class IIImubind Plasma Pai-1 Elisa,model 822American Diagnostica, Inc. / cleared 2002-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)