Stanbio Laboratory, Inc Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.
Brand
Stanbio Laboratory, Inc
Lot Codes / Batch Numbers
Control #05276CE, kit contains Lot #23651 and Lot #23652, (Pointe Scientific Lot #523002).
Products Sold
Control #05276CE; kit contains Lot #23651 and Lot #23652; (Pointe Scientific Lot #523002).
Stanbio Laboratory, Inc is recalling Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL co due to Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
Recommended Action
Per FDA guidance
Firm notified consignees via letter on 09/20/06.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026