Z-1449-2014 Class II Terminated
FDA device recall Z-1449-2014 was initiated by Roche Diagnostics Operations, Inc. on Mar 13, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 10, 2018). Affected quantity: 76 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 16, 2014
- Initiation Date
- Mar 13, 2014
- Termination Date
- Jan 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 units
Product Description
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.
Reason for Recall
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
Distribution Pattern
USA Nationwide Distribution including San Juan PR
Code Information
not applicable
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1449-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026