FDAFDA · Food and drugs·Recall number Z-1449-2014
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
Published April 16, 2014 · Recall initiated: March 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas 8000 modular analyzer series when manually filled cobas c packs are loaded. This issue occurs with tests that use cobas c pack MULTI or empty pre-labeled cobas c packs. The ICVC feature allows the reagent probe to dive into the reagent cassette and confirm the reagent level in the bottles. This ensures
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- USA Nationwide Distribution including San Juan PR
- Lot
- not applicable
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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