Recall Z-2981-2020— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-2981-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-20

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2020-08-20, terminated 2021-10-22. It names one FDA 510(k) clearance: K051890. Product: Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190. Reason: Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-20
Terminated: 2021-10-22
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K051890 — ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPORoche Diagnostics Corp.·cleared 2005-08-04

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

Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190

Reason for recall

Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.

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