Liquid Glucose Hexokinase Reagent Recalled Due to Test FailuresNov 2, 2009 | Parker Waichman LLP
Pointe Scientific, Inc. has issued a recall of its Liquid Glucose Hexokinase Reagent due to test failures, according to the U.S. Food and Drug Administration (FDA).
Pointe Scientific, Inc, located in Canton, Michigan 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 recalled Pointe Scientific, Inc. Liquid Glucose Hexokinase Reagent (G7517) should destroy remaining inventory. The recall includes ALL BATCHES of the following lots and expiration dates:
- Lot # 823901: Expiration: 2010-02
- Lot # 826801: Expiration: 2010-03
- Lot # 829401: Expiration: 2010-04
- Lot # 831502: Expiration: 2010-05
The catalog numbers and kit breakdowns involved in the recall follow:
- 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 (3 bottles)
Pointe Scientific, Inc. voluntarily recalled the Liquid Glucose products after confirming a reported assay (test) failure in Lot 826801. Testing laboratories should consider all test results obtained with the lot numbers listed here to be questionable and should inform the patient’s attending physician, and determine, with the physician’s 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.
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. The product involved in the recall can be identified by any of the lot numbers listed here and 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: www.fda.gov/medwatch/report.htm; by 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; or by Fax: 1-800-FDA-0178