Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HD
FDA device recall Z-0075-2007 · posted 2006-11-14 · Terminated
Recall details
- Recalling firm
- Stanbio Laboratory, Inc
- Reason for recall
- Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Action taken
- Firm notified consignees via letter on 09/20/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- LBR
- Quantity affected
- 05276CE: 78 test kits; 05312CE: 6 test kits; 05299CE: 10 test kits.
- Distribution
- Worldwide, including USA, Korea, Thailand, Venezuela and Mexico.
- Date initiated
- 2006-09-18
- Date posted
- 2006-11-14
- Date terminated
- 2007-06-06
- Location
- Boerne, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOHDL CHOLESTEROL REAGENT SET (K992002) | Pointe Scientific, Inc., | 1999-08-05 |