Pointe Scientific, Inc. Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Reagent Set, 2MM Corporation, Miami, FL; Reorder # RT-160-500. Pointe Scientific Glucose Oxidase Reagent, Pointe Scientific, Inc., Canton, MI; Catalog, MI; Catalog # 2-G7519-L, 7-G7519-100, 7-G7519-200, 7-G7519-1000, 8-G7519-100, and 12-RT-160-500. For the quantitative determination of Glucose in h Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The product is unable to maintain the specification for linearity through the shelf life of the product.

Recommended Action

Per FDA guidance

Consignees were notified via an Urgent: Medical Device Recall letter dated 11/3/08 that all test results obtained with these lots are questionable and that attending physicians should be informed to determine whether additional testing is required. Also, consignees should examine their inventories for any of the lot numbers listed and dispose of them. If the product has been further distributed, identify customers and notify them of the product recall by including a copy of the recall letter. The Recall Return Response Form should be completed and returned and upon receipt Pointe Scientific will replace any disposed of reagent. Questions should be directed to the Technical Support Department at 1-800-757-5313.