| Subject: | Recall of Pointe Scientific Liquid Glucose Hexokinase Reagent Reclassified to Class I |
| Category: | Food and Drug Administration (FDA)
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| Published: | Tue, 10 Nov 2009 - 10:00 am |
| The Food and Drug Administration (FDA) and Pointe Scientific are notifying healthcare professionals that the nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517 has been upgraded to a Class I recall. As reviewed in the StayAlert Notice dated November 2, 2009, 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 recalled... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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