FDA Medical Device Recalls (openFDA)
Meridian Bioscience Inc: 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.
- Recall number
- Z-1203-06
- Recalling firm
- Meridian Bioscience Inc
- 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.
- Status
- Terminated
- Initiated
- 2006-06-02
- Posted
- 2006-07-04
- Terminated
- 2012-02-16
- Reason
- 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.
- Root cause
- Other
- Action
- The recalling firm sent a recall letter dated 6/2/06 to their customers.
- Quantity
- 704
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 712050.066, expiration date 2007-02-22 and Lot 712050.068, expiration date 2007-03-08.
- 510(k) numbers
- K041003
- PMA numbers
- not on file
- Product code
- LLH
- Firm FEI
- 1524213
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28