PerkinElmer LIfe Sciences Inc
Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050.
| Date | Jul 2, 2003 (initiated May 16, 2002) |
| Status | Terminated |
| Reason | The CSF Gels were manufactured incorrectly resulting in irregular wavy bands. |
| Root cause | Other |
| Action | The firm contacted the consignee by telephone on 5/16/2002. |
| Quantity | 10 kits |
| Distribution | The kits were shipped to one (1) consignee located in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843122 | RESOLVE-CSF Isolab, Inc., Nov 30, 1984 |