Roche Diagnostics Operations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2981-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 20, 2020

Date Posted: September 23, 2020

Recall Number: Z-2981-2020

Event ID: 86319

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.

Status: Terminated

Product Quantity: 11,870 reagent kits

Code Information:

All current and upcoming lots

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated