Recall Z-1091-2009 ยท CGA Glucose Oxidase, Glucose
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-G7519-20
| Date | Mar 12, 2009 (initiated Nov 3, 2008) |
| Status | Terminated |
| Reason | The product is unable to maintain the specification for linearity through the shelf life of the product. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 1500 liters |
| Distribution | Worldwide Distribution -- USA, Hong Kong, Indonesia, Israel, Jordan, Mexico, Nigeria, Poland, Russia, Serbia, Sri Lanka, Trinidad, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810674 | GLUCOSE OXIDASE Pointe Scientific, Inc.,, Mar 31, 1981 |