Roche Diagnostics Corporation: Medical Device Recall in 2018 - (Recall #: Z-1268-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692

Product Classification:

Class II

Date Initiated: December 18, 2017

Date Posted: April 4, 2018

Recall Number: Z-1268-2018

Event ID: 79074

Reason for Recall:

Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.

Status: Terminated

Product Quantity:

Code Information:

None

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated