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Terminated

Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).

FDA Recall Z-1435-04 · Posted 2004-09-02

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCIT
Date Initiated2004-08-20
Date Terminated2004-11-05
Product Quantity757non-expired kits.

Reason for Recall

Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.

Firm Action

Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

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

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