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Terminated

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.

FDA Recall Z-0075-2007 · Posted 2006-11-14

Recalling FirmStanbio Laboratory, Inc
Recall StatusTerminated
Product CodeLBR
Date Initiated2006-09-18
Date Terminated2007-06-06
Product Quantity05276CE: 78 test kits; 05312CE: 6 test kits; 05299CE: 10 test kits.

Reason for Recall

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

Firm Action

Firm notified consignees via letter on 09/20/06.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Korea, Thailand, Venezuela and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, Inc., · 1999-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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