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Terminated

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

FDA Recall Z-0899-06 · Posted 2006-05-25

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCFR
Date Initiated2006-04-12
Date Terminated2006-10-16
Product Quantity269 kits

Reason for Recall

A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.

Firm Action

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

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K854025HITACHI 704Boehringer Mannheim Corp. · 1985-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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