Roche Diagnostics Corporation: Medical Device Recall in 2018 - (Recall #: Z-2136-2018)

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 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.

Product Classification:

Class II

Date Initiated: April 3, 2018

Date Posted: June 20, 2018

Recall Number: Z-2136-2018

Event ID: 79805

Reason for Recall:

The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.

Status: Terminated

Product Quantity: 35

Code Information:

Serial numbers: 1744-08 1744-09 1744-10 1758-08 1606-09 1752-05 1752-06 1630-08 1738-01 1744-07 1758-09 1759-04 1758-06 1758-07 1743-09 1743-10 1752-04 1759-05 17C5-06 17C5-07 1615-08 1612-10 17C5-09 1744-05 1744-06 1743-07 1743-08 1744-03 1744-04 1759-06 17C5-05 17C5-08 17C5-10 17C6-01 17C6-02

Distribution Pattern:

US Distribution to the states of : CA, CT, IA, IN, KY, ME, MI, NC, NY, OH, SC, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated