Recall Z-1372-04 ยท LQP Campylobacter Spp.
Remel, Inc.
ProSpecT Campylobacter Microplate Assay. Catalog #2476096.
| Date | Aug 17, 2004 (initiated Jul 15, 2002) |
| Status | Terminated |
| Reason | A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged. |
| Root cause | Other |
| Action | Remel contacted the customer with a letter, requesting a count of the affected lot, and offered replacement of the kits. |
| Quantity | 382 |
| Distribution | Entire lot was shipped to one customer in Russelsheim, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982315 | PROSPECT CAMPYLOBACTER MICROPLATE ASSAY Alexon - Trend, Inc., Nov 18, 1998 |