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U.S. Department of Health and Human Services

Safety

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Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall

Audience: Clinical lab managers, hospital risk managers

[UPDATED 11/06/2009] Recall classified as Class I.

[UPDATED 11/2/2009] Firm press release added, dated 10/30/2009.

[Posted 10/30/2009] Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.

Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable. The laboratory should inform the patient’s attending physician, and determine, with their input, whether confirmation of the previous test results will be required.

[11/06/2009 - Recall Notice - FDA]
[10/28/2009 - Press Release - Pointe Scientific]
[10/30/2009 - Press Release - Pointe Scientific]