Pointe Scientific, Inc Expands Nationwide Recall of Liquid Glucose Hexokinase Reagent (G7517)

Date of Recall

2009-10-31

Recall Details

- October 30, 2009 - Pointe Scientific, Inc, Canton, MI 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

Catalog # s of these lots all begin with G7517and the quantities are yet to be determined.
The firm voluntarily recalled the products after confirming a reported assay failure in Lot 826801. FDA has been apprised of this action.

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.

To date, the firm is not aware of any injuries or inaccurate results being reported out.

The Pointe Scientific, Inc Liquid Glucose Hexokinase Reagent (G7517) was distributed to medical device distributors and/or drop-shipped to testing laboratories nationwide by courier delivery service. Product involved in the recall can be identified by any of the lot numbers listed above appearing on the Pointe Scientific, Inc kit content label, vial label or bulk container label.

Pointe Scientific, Inc has notified its distributors and drop-ship customers by e-mail, fax, telephone and/or certified mail and is arranging for replacement of all recalled products.

Distributors and testing laboratories with questions may contact the company at 1-800-445-9853.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

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