Pointe Scientific Liquid Glucose Hexokinase Reagent Recalled, FDA Says

A nationwide recall has just been announced for all size kits of Pointe Scientific Liquid Glucose Hexokinase Reagent catalog number G7517, which may fail to deliver accurate glucose value results.

In testing of samples from one lot, the reagents were found to fail linearity at >200mg/dL. Therefore, results in glucose values above this range may be inaccurate, the company and Food and Drug Administration said.

Select Lots and Expiration Dates Recalled

Today’s recall includes the following lot numbers of Pointe Scientific reagent catalog number 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

Distributors and testing laboratories who have received the recalled Liquid Glucose Hexokinase Reagent (G7517) should destroy remaining inventory, the FDA said. In some cases, retesting and confirmation of previous glucose test levels administered using the recalled reagent may be necessary, officials said.

The company said it is not aware of any incidents in which injuries or inaccurate test results occurred due to the use of the reagents. Adverse events associated with their use can be reported to the company.

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