Roche Diagnostics Corporation: Medical Device Recall in 2018 - (Recall #: Z-1270-2018)

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:

cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).

Product Classification:

Class II

Date Initiated: December 18, 2017

Date Posted: April 4, 2018

Recall Number: Z-1270-2018

Event ID: 79074

Reason for Recall:

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

Status: Terminated

Product Quantity:

Code Information:

None

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated