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Terminated

Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.

FDA Recall Z-1441-06 · Posted 2006-08-26

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGFO
Date Initiated2006-07-18
Date Terminated2006-11-06
Product Quantity4,365 kits

Reason for Recall

Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

Firm Action

Recall notification letters were sent out via first class mail on July 18, 2006.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923731STACLOT LA TEST KITAmerican Bioproducts Co. · 1992-12-23

Official Source

View FDA Recall →

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

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