Roche Diagnostics Corp. Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lot 672652, exp. 6/30/2007.
Products Sold
Lot 672652; exp. 6/30/2007.
Roche Diagnostics Corp. is recalling Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 ( due to A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.
Recommended Action
Per FDA guidance
A recall notification letter dated 4/12/06 was sent to each customer instructing them to discontinue use of this lot of product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026