Recall Z-0489-2025— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-0489-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-17

Class II · Ongoing

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2024-10-17. It names one FDA 510(k) clearance: K113793. Product: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine. Reason: Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias).

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-10-17
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K113793 — HOMOCYSTEINE TESTRoche·cleared 2012-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.