Recall Z-1328-06 ยท CFR Hexokinase, Glucose
Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative determination of glucose in serum, 10 x 5 ml R1 and 5 x 20 ml R2, or 9 x 67 ml R1and 9 x 17 ml R2 glucose reagent, for use with Hitachi analyzer; in vitro diagnostic, Catalog numbers HG720-600 and HG920-756.
| Date | Aug 3, 2006 (initiated Jun 7, 2006) |
| Status | Terminated |
| Reason | Product does not meet performance specifications through its labeled expiration period. |
| Root cause | Other |
| Action | Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks. |
| Quantity | 10 kits |
| Distribution | Worldwide, including USA, Canada, China, Panama, Russia and Trinidad. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET Pointe Scientific, Inc.,, Nov 20, 2000 |