ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Sto
FDA device recall Z-1203-06 · posted 2006-07-04 · Terminated
Recall details
- Recalling firm
- Meridian Bioscience Inc
- 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.
- Action taken
- The recalling firm sent a recall letter dated 6/2/06 to their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLH
- Quantity affected
- 704
- Distribution
- Nationwide.
- Date initiated
- 2006-06-02
- Date posted
- 2006-07-04
- Date terminated
- 2012-02-16
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMUNOCARD TOXINS A & B, MODEL 712050 (K041003) | Meridian Bioscience, Inc. | 2004-08-20 |