Recall Z-1203-06 ยท LLH Reagents, Clostridium Difficile Toxin
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.
| Date | Jul 4, 2006 (initiated Jun 2, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041003 | IMMUNOCARD TOXINS A & B, MODEL 712050 Meridian Bioscience, Inc., Aug 20, 2004 |