Roche Diagnostics Operations, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0489-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

Product Classification:

Class II

Date Initiated: October 17, 2024

Date Posted: November 27, 2024

Recall Number: Z-0489-2025

Event ID: 95609

Reason for Recall:

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

Status: Ongoing

Product Quantity: 458 units

Code Information:

UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024

Distribution Pattern:

US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,

Voluntary or Mandated:

Voluntary: Firm initiated