FDA Recall Terminated

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.

Recall: Z-0104-2010 · Initiated October 19, 2009

Recall

Recall Number: Z-0104-2010
Event Number: 53583
Firm: Pointe Scientific, Inc.
FEI Number: 1827821
Product Code: CFR
Status: Terminated
Root Cause: Process design
Initiated: October 19, 2009
Posted: November 4, 2009
Terminated: September 27, 2010
Address: 5449 Research Dr, Canton, MI, 48188

Description

Reason

There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.

Action

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.

Distribution

Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.

Quantity

400 kits plus 59 liters and 15 vials.