Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0152-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.

Product Classification:

Class III

Date Initiated: September 11, 2019

Date Posted: October 23, 2019

Recall Number: Z-0152-2020

Event ID: 83806

Reason for Recall:

Due to low Quality Control recovery and invalid Calibration.

Status: Terminated

Product Quantity: 7,032 units (Expanded on 12/20/19 to include 29,696 additional units)

Code Information:

Lot # 33962301. Expanded on 12/20/19 to include lot 37437301

Distribution Pattern:

US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.

Voluntary or Mandated:

Voluntary: Firm initiated