Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050.
FDA device recall Z-0973-03 · posted 2003-07-02 · Terminated
Recall details
- Recalling firm
- PerkinElmer LIfe Sciences Inc
- Reason for recall
- The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.
- Action taken
- The firm contacted the consignee by telephone on 5/16/2002.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 10 kits
- Distribution
- The kits were shipped to one (1) consignee located in California.
- Date initiated
- 2002-05-16
- Date posted
- 2003-07-02
- Date terminated
- 2008-10-24
- Location
- Norton, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESOLVE-CSF (K843122) | Isolab, Inc. | 1984-11-30 |