Z-0913-2010

Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1...

Name: Z-0913-2010 Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1...
Creator: Pointe Scientific, Inc.
Published: 2009-12-01
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-12-01 / Terminated / root cause: design

FDA source

Pointe Scientific, Inc. began a recall of Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid... on 2009-12-01. The reason FDA records is "A process deviation occurred during the production of the R1 component which may affect its performance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0913-2010
Status: Terminated
Initiated: 2009-12-01
Posted: 2010-03-02
Terminated: 2010-10-08
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
Product code: KNK Acid, Uric, Uricase (Colorimetric)
Reason for recall: A process deviation occurred during the production of the R1 component which may affect its performance.
Root cause tag: design
FDA root cause: Device Design
Action: Pointe Scientific, Inc. issued an "Urgent: Medical Device Recall" notification dated December 1, 2009. Consignees were instructed to examine their inventory for the affected product and discard the affected product immediately. For further information, contact Pointe Scientific, Inc. Technical Support at 1-800-757-5313 or 1-734-487-8300.
Quantity in commerce: 1 kit
Distribution: Worldwide Distribution -- United States (California, Florida, Kentucky, Michigan, Ohio, Oklahoma and Virginia), Chile and Malaysia.
Product codes and lots: All lot numbers containing the numbers 918301; exp. 2011-01.

Product code KNK

K970560Class IUric Acid (Liquid) Reagent SetPointe Scientific, Inc., / cleared 1997-03-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)