Z-2764-2015Class III

Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000...

Name: Z-2764-2015 Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000...
Creator: Pointe Scientific, Inc.
Published: 2015-03-13
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2015-03-13 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2... on 2015-03-13. FDA classified it as Class III and gives the reason as "Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2764-2015
Classification: Class III
Status: Terminated
Initiated: 2015-03-13
Posted: 2015-09-14
Terminated: 2015-10-29
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
Product code: LBR Ldl & Vldl Precipitation, Hdl
Reason for recall: Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Pointe Scientific sent a Field Correction Notice on March 13, 2015, to all affected customers via fax, email, and mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Technical Service Department at 1-800-757-5313.
Quantity in commerce: H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits
Distribution: Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
Product codes and lots: Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2764-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2764-2015	Class III	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-16

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)