Z-0104-2010

Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s...

Name: Z-0104-2010 Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s...
Creator: Pointe Scientific, Inc.
Published: 2009-10-19
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-10-19 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120... on 2009-10-19. The reason FDA records is "There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL". 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-0104-2010
Status: Terminated
Initiated: 2009-10-19
Posted: 2009-11-04
Terminated: 2010-09-27
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.
Product code: CFR Hexokinase, Glucose
Reason for recall: There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm issued a press release, and an amended press release, on 10/30/09. Consignees were notified by an Urgent: Medical Device Recall letter dated 10/19/09, which identified the problem; and, instructed testing laboratories to inform patients' attending physicians, and determine, with their input, whether confirmation of the previous test results will be required. Customers are to examine their inventory for any of the lot numbers listed on the letter; and, for any product that has been further distributed, those customers need to be identified and notified of this product recall by including a copy of the recall letter. Customers are to complete and return the Recall Return Response form and upon receipt, Pointe Scientific will replace any disposed of reagent. The recall was expanded to include two additional lots by letter dated 11/2/09.
Quantity in commerce: 400 kits plus 59 liters and 15 vials.
Distribution: Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.
Product codes and lots: All lots beginning with the numbers 814301, 820502, 823901, 826801, 829401, 814301, 820502, and 831502.

Product code CFR

K971754Class IILiquid Glucose (Hexokinase) Reagent SetPointe Scientific, Inc., / cleared 1997-07-22

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)