—#34737

Product

Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).

FDA product code: CKH — Acid Phosphatase, Beta Glycerophosphate
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: All lots expiring on or before 11/05.

Why it was recalled

Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.

Root cause (FDA determination)

Other

Action the firm took

Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2004-08-20
Posted by FDA: 2004-09-02
Terminated: 2004-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34737. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.