Z-1201-2009

Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog...

Name: Z-1201-2009 Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog...
Creator: Pointe Scientific, Inc.
Published: 2009-01-29
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-01-29 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L... on 2009-01-29. The reason FDA records is "The R1 reagent has microbial contamination". 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-1201-2009
Status: Terminated
Initiated: 2009-01-29
Posted: 2009-04-27
Terminated: 2010-10-20
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
Product code: LBR Ldl & Vldl Precipitation, Hdl
Reason for recall: The R1 reagent has microbial contamination.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were notified by "Urgent: Medical Device Recall" letter dated January 29, 2009, to conduct the recall to the retail level, to examine inventory and dispose of affected stocks on hand, and to complete the "Recall Return Response Form". Consignees were instructed to return their completed forms via mail, fax (1-734-483-1592) or e-mail to Pointe Scientific, Inc. (PS). Direct questions about the recall to PS Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
Quantity in commerce: 717 kits, 164L
Distribution: Worldwide Distribution -- US, Chile, Dominican Republic, Egypt, Ghana, Greece, India, Israel, Italy, Jamaica-West Indies, Korea, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Trinidad-West Indies, Turkey and Venezuela.
Product codes and lots: Lot Number: 818202, exp. 12/09.

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)