Recall Z-0076-2007 ยท LBR Ldl & Vldl Precipitation, Hdl
Stanbio Laboratory, Inc
Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL 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 | 9 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 |