Recall Z-0075-2007 ยท LBR Ldl & Vldl Precipitation, Hdl
Stanbio Laboratory, Inc
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.
| Date | Nov 14, 2006 (initiated Sep 18, 2006) |
| Status | Terminated |
| Reason | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Root cause | Other |
| Action | Firm notified consignees via letter on 09/20/06. |
| Quantity | 05276CE: 78 test kits; 05312CE: 6 test kits; 05299CE: 10 test kits. |
| Distribution | Worldwide, including USA, Korea, Thailand, Venezuela and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992002 | AUTOHDL CHOLESTEROL REAGENT SET Pointe Scientific, Inc.,, Aug 5, 1999 |