Recall Z-0770-04 ยท MHI Giardia Spp.
Genzyme Diagnostics
Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay
| Date | Jul 20, 2004 (initiated Feb 23, 2004) |
| Status | Terminated |
| Reason | False Positive results. |
| Root cause | Other |
| Action | Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question. |
| Quantity | 2671 kits |
| Distribution | Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY Genzyme Diagnostics, Jan 11, 1999 |