Roche Diagnostics Operations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0104-2021)

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:

Albumin Gen.2, Catalog 05166861190

Product Classification:

Class III

Date Initiated: August 27, 2020

Date Posted: October 21, 2020

Recall Number: Z-0104-2021

Event ID: 86406

Reason for Recall:

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

Status: Terminated

Product Quantity: 11963

Code Information:

lots 43031001, 43718901

Distribution Pattern:

Domestic distribution nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated