ImmunoCard Toxins A & B Kit (Meridian Bioscience) – Non-specific Reactions (2006)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Meridian Bioscience Inc
Lot Codes / Batch Numbers
Lot 712050.066, expiration date 2007-02-22 and Lot 712050.068, expiration date 2007-03-08.
Products Sold
Lot 712050.066, expiration date 2007-02-22 and Lot 712050.068, expiration date 2007-03-08.
Meridian Bioscience Inc is recalling ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile T due to The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm sent a recall letter dated 6/2/06 to their customers.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026