FDA Medical Device Recalls (openFDA)
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 number
- Z-0074-2007
- Recalling firm
- Stanbio Laboratory, Inc
- 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.
- Status
- Terminated
- Initiated
- 2006-09-18
- Posted
- 2006-11-14
- Terminated
- 2007-06-06
- 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
- 47 test kits.
- Distribution
- Worldwide, including USA, Korea, Thailand, Venezuela and Mexico.
- Lot, serial or model codes
- Control #05276CE; kit contains Lot #23651 and Lot #23652; (Pointe Scientific Lot #523002).
- 510(k) numbers
- ["K992002"]
- PMA numbers
- not on file
- Product code
- LBR
- Firm FEI
- 1616487
- Firm city
- Boerne
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28