Recall Z-1219-03 ยท LYR Helicobacter Pylori
Diagnostic Products Corp
Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
| Date | Sep 11, 2003 (initiated Jul 31, 2003) |
| Status | Terminated |
| Reason | Kits had parts in them that did not belong in the kit. |
| Root cause | Other |
| Action | Customers have been informed to discard kits with the incorrect adjustors in them by fax delivered on 7/31/2003. |
| Quantity | 339 |
| Distribution | US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000463 | IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG Diagnostic Products Corp., Jun 1, 2000 |