Z-0389-2019Class III

Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL -

Name: Z-0389-2019 Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL -
Creator: Medtest Holdings, Inc.
Published: 2018-08-10
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2018-08-10 / Terminated / root cause: labeling and UDI

FDA source

Medtest Holdings, Inc. began a recall of Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL... on 2018-08-10. FDA classified it as Class III and gives the reason as "Vials of the autoHDL/LDL Calibrator were shipped without a vial label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0389-2019
Classification: Class III
Status: Terminated
Initiated: 2018-08-10
Posted: 2018-11-05
Terminated: 2019-12-04
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
Product code: LBR Ldl & Vldl Precipitation, Hdl
Reason for recall: Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Notification letters dated 8/14/18 were sent to customers. Customers were also contacted via telephone on 8/10/18. Additional letters containing labels dated 8/17/18 were sent to customers.
Quantity in commerce: 22
Distribution: US Nationwide in the states of CA, FL, GA, MI, and OH.
Product codes and lots: Lot Number 808801-180; UDI: 00811727011411

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0389-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0389-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-05

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)