Recall : Pointe Scientific Expanded Recall : Liquid Glucose Hexokinase Reagent (G7517)

I posted this late last week, but now they’re expanding the recall/trash notice to ALL their kits. Not good. If a Pointe Scientific is on your cart or station, you might want to do a quick check against these numbers.

The new recall states… “Pointe Scientific… is initiating 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 Pointe Scientific, Inc Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.”

“The recall includes the following lot numbers:
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
Catalog #s:  G7517-120 (97 kits), G7517-500(129 kits), G7517-1L (31), 8-G7517-120 (15 vials), 8-G7517-500 (21vials), 3-G7517-L (28L), 7-G7517-500 (5 vials). 7-G7517-1000 (3bottles)
Lot #814301 (all batches)      Expiration:  2009-11
Lot# 820502 (all batches)       Expiration: 2010-01”

“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.”

Here’s the link to the official FDA recall notice.