Roche Diagnostics Operations, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1449-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 13, 2014

Date Posted: April 16, 2014

Recall Number: Z-1449-2014

Event ID: 67762

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

Status: Terminated

Product Quantity: 76 units

Code Information:

not applicable

Distribution Pattern:

USA Nationwide Distribution including San Juan PR

Voluntary or Mandated:

Voluntary: Firm initiated