Recall Z-0899-06 ยท CFR Hexokinase, Glucose
Roche Diagnostics Corp.
Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.
| Date | May 25, 2006 (initiated Apr 12, 2006) |
| Status | Terminated |
| Reason | A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported. |
| Root cause | Other |
| Action | A recall notification letter dated 4/12/06 was sent to each customer instructing them to discontinue use of this lot of product. |
| Quantity | 269 kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854025 | HITACHI 704 Boehringer Mannheim Corp., Oct 28, 1985 |