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Terminated

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.

FDA Recall Z-1426-2010 · Posted 2010-04-21

Recalling FirmAmerican Diagnostica, Inc.
Recall StatusTerminated
Product CodeGGP
Date Initiated2010-03-05
Date Terminated2016-07-29
Product Quantity25 kits

Reason for Recall

Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution: USA and UK, Taiwan and Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013168IMUBIND PLASMA PAI-1 ELISA,MODEL 822American Diagnostica, Inc. · 2002-03-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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