Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian Immuno
FDA device recall Z-0770-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Genzyme Diagnostics
- Reason for recall
- False Positive results.
- Action taken
- Recall was by letters sent in March 2004 requesting distributors subrecall to customers and have them discard/destroy the lots in question.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHI
- Quantity affected
- 2671 kits
- Distribution
- Product was manufactured for two firms who subdistributed it, Meridian Bioscience of Cincinnati OH and Becton Dickenson, Sparks MD.
- Date initiated
- 2004-02-23
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-15
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY (K983399) | Genzyme Diagnostics | 1999-01-11 |