—#45153

Product

Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.

FDA product code: CFR — Hexokinase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K854025
Affected lot / code info: Lot 672652; exp. 6/30/2007.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

A recall notification letter dated 4/12/06 was sent to each customer instructing them to discontinue use of this lot of product.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-04-12
Posted by FDA: 2006-05-25
Terminated: 2006-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45153. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.