Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0679-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.

Product Classification:

Class II

Date Initiated: October 4, 2019

Date Posted: December 25, 2019

Recall Number: Z-0679-2020

Event ID: 84018

Reason for Recall:

Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules

Status: Terminated

Product Quantity: 82 units (US)

Code Information:

Lot Number: 422313 Exp Date: 07/31/2020

Distribution Pattern:

US Nationwide distribution in the states of NJ, HI, IA.

Voluntary or Mandated:

Voluntary: Firm initiated