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U.S. Department of Health and Human Services

Medical Devices

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Pointe Scientific, Inc., Liquid Glucose Hexokinase Reagent (G7517)

Recall Class: Class I
Date Recall
Initiated:
October 19, 2009
Product:

Pointe Scientific Inc., Liquid Glucose Hexokinase Reagent (catalog number G7517)

All size kits of Liquid Glucose Hexokinase Reagent with a catalog number of G7517 are being recalled.

The lot number is found on the kit content label, vial label or bulk container label.

Catalog Numbers Lot Numbers and Expiration Dates
G7517 Lot # 823901 (all batches) Expiration: 2010-02
Lot # 826801 (all batches) Expiration: 2010-03
Lot # 829401 (all batches) Expiration: 2010-04
Lot # 831502 (all batches) Expiration: 2010-05
G7517-120
G7517-500
G7517-1L
8-G7517-120
8-G7517-500
3-G7517-L
7-G7517-500
7-G7517-1000
Lot #814301 (all batches) Expiration:2009-11
Lot# 820502 (all batches) Expiration: 2010-01
These products were manufactured from May 22, 2008 through September 18, 2009 and distributed from July 8, 2008 through June 3, 2009.
Use: This product is used to determine the amount of glucose in the blood.
Recalling Firm: Pointe Scientific, Inc.
5449 Research Drive
Canton, Michigan 48188
Reason for Recall: Laboratories are unable to recover patient samples above 200mg/dL that results in inaccurate glucose values above this range.
Public Contact:

The company may be contacted at 1-800-445-9853. This phone number is answered from 8:30am to 5:00pm, Monday to Friday, Eastern Time. During other times, the caller is instructed to leave a message and contact information.

For more information, see Useful Links below.

FDA District: Detroit
FDA Comments:

On October 19, 2009, the company notified distributors and testing laboratories about the problem and instructed them to:

  • destroy the products
  • return the business reply card to the firm to replace the recalled products.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

Useful Links: