Z-0075-2007

Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container...

Name: Z-0075-2007 Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container...
Creator: Stanbio Laboratory, Inc
Published: 2006-09-18
License: https://open.fda.gov/license/

Stanbio Laboratory / initiated 2006-09-18 / Terminated

FDA source

Stanbio Laboratory, Inc began a recall of Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL... on 2006-09-18. The reason FDA records is "Unexpected changes in QC and proficiency results due to QC and proficiency material matrix". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0075-2007
Status: Terminated
Initiated: 2006-09-18
Posted: 2006-11-14
Terminated: 2007-06-06
Recalling firm: Stanbio Laboratory
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.
Product code: LBR Ldl & Vldl Precipitation, Hdl
Reason for recall: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
FDA root cause: Other
Action: Firm notified consignees via letter on 09/20/06.
Quantity in commerce: 05276CE: 78 test kits; 05312CE: 6 test kits; 05299CE: 10 test kits.
Distribution: Worldwide, including USA, Korea, Thailand, Venezuela and Mexico.
Product codes and 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.

Product code LBR

K992002Class IAutohdl Cholesterol Reagent SetPointe Scientific, Inc., / cleared 1999-08-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)