Recalls / —
—#34738
Product
Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).
- FDA product code
- CIT — Nadh Oxidation/Nad Reduction, Ast/Sgot
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- All lots expiring on or before 7/05.
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 #34738. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.