Recall Z-1374-04 ยท MHI Giardia Spp.
Remel, Inc.
ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496.
| Date | Aug 17, 2004 (initiated Nov 21, 2002) |
| Status | Terminated |
| Reason | The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that the reagents were still performing as intended, including the conjugates. |
| Root cause | Other |
| Action | A potential contamination was noted in the conjugate in the ProSpecT Giardia/Cryptosporidium Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged. |
| Quantity | 12 |
| Distribution | US only |
| 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 |