Z-1457-06

AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density...

Name: Z-1457-06 AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density...
Creator: Pointe Scientific, Inc.
Published: 2006-06-12
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2006-06-12 / Terminated

FDA source

Pointe Scientific, Inc. began a recall of AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma... on 2006-06-12. 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-1457-06
Status: Terminated
Initiated: 2006-06-12
Posted: 2006-08-30
Terminated: 2007-11-19
Recalling firm: Horiba Instruments Incorporated
Product: AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catalogs HH445-R2.
Product code: CCH
Reason for recall: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
FDA root cause: Other
Action: Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
Quantity in commerce: To be determined
Distribution: Worldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela.
Product codes and lots: Lots 523002, exp. 2/07, and 531801, exp. 2/07.

Product code CCH

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)