Recall Z-1375-04 ยท MHI Giardia Spp.
Remel, Inc.
ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496.
| Date | Aug 17, 2004 (initiated Dec 9, 2003) |
| Status | Terminated |
| Reason | The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run. |
| Root cause | Other |
| Action | Remel contacted each customer with a letter, by mail, requesting a count of the affected lots to be returned. Product would be replaced upon customer request. |
| Quantity | 127 kits |
| Distribution | US and OUS customers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY Alexon Biomedical, Inc., Feb 9, 1996 |