Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
FDA device recall Z-1219-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Diagnostic Products Corp
- Reason for recall
- Kits had parts in them that did not belong in the kit.
- Action taken
- Customers have been informed to discard kits with the incorrect adjustors in them by fax delivered on 7/31/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYR
- Quantity affected
- 339
- Distribution
- US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria
- Date initiated
- 2003-07-31
- Date posted
- 2003-09-11
- Date terminated
- 2003-12-30
- Location
- Los Angeles, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG (K000463) | Diagnostic Products Corp. | 2000-06-01 |