Recall Z-0075-2007
Stanbio Laboratory, Inc · initiated September 18, 2006
Product
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.
Codes / lots: Control #05276CE, 05312CE and 05299CE; kit contains Lot #23651 and Lot #23652; (Pointe Scientific Lot #523002). Note: Kits with Control #05312CE produced by repackaging 12 kits of Cat #0590-040 with Control #05276CE.
Reason for recall
Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
FDA-determined cause: Other
Action taken
Firm notified consignees via letter on 09/20/06.
Details
- Recall number
- Z-0075-2007
- Initiated
- September 18, 2006
- Posted by FDA
- November 14, 2006
- Terminated
- June 6, 2007
- Product code
- LBR – Ldl & Vldl Precipitation, Hdl
- Quantity
- 05276CE: 78 test kits; 05312CE: 6 test kits; 05299CE: 10 test kits.
- Distribution
- Worldwide, including USA, Korea, Thailand, Venezuela and Mexico.
- Recalling firm
- Stanbio Laboratory, Inc, Boerne, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0074-2007 | Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit…Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | 09/18/2006Terminated |
| Z-0076-2007 | Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit…Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | 09/18/2006Terminated |