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Terminated

ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic.

FDA Recall Z-1203-06 · Posted 2006-07-04

Recalling FirmMeridian Bioscience Inc
Recall StatusTerminated
Product CodeLLH
Date Initiated2006-06-02
Date Terminated2012-02-16
Product Quantity704

Reason for Recall

The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.

Firm Action

The recalling firm sent a recall letter dated 6/2/06 to their customers.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041003IMMUNOCARD TOXINS A & B, MODEL 712050Meridian Bioscience, Inc. · 2004-08-20

Official Source

View FDA Recall →

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

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