Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.
This recall has been terminated (originally issued November 4, 2009).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- October 19, 2009
- Posted
- November 4, 2009
- Terminated
- September 27, 2010
- Recall Number
- Z-0104-2010
- Quantity
- 400 kits plus 59 liters and 15 vials.
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
Distribution
Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.
Lot / Code Info
All lots beginning with the numbers 814301, 820502, 823901, 826801, 829401, 814301, 820502, and 831502.
Root Cause
Process design
Action Taken
The firm issued a press release, and an amended press release, on 10/30/09. Consignees were notified by an Urgent: Medical Device Recall letter dated 10/19/09, which identified the problem; and, instructed testing laboratories to inform patients' attending physicians, and determine, with their input, whether confirmation of the previous test results will be required. Customers are to examine their inventory for any of the lot numbers listed on the letter; and, for any product that has been further distributed, those customers need to be identified and notified of this product recall by including a copy of the recall letter. Customers are to complete and return the Recall Return Response form and upon receipt, Pointe Scientific will replace any disposed of reagent. The recall was expanded to include two additional lots by letter dated 11/2/09.