Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0095-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.

Product Classification:

Class II

Date Initiated: July 15, 2016

Date Posted: November 2, 2016

Recall Number: Z-0095-2017

Event ID: 75186

Reason for Recall:

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

Status: Terminated

Product Quantity: 9014 in total

Code Information:

Not applicable

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated