Roche Diagnostics Operations, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1675-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

Product Classification:

Class II

Date Initiated: April 26, 2021

Date Posted: June 2, 2021

Recall Number: Z-1675-2021

Event ID: 87854

Reason for Recall:

Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

Status: Ongoing

Product Quantity: 20,468 kits

Code Information:

UDI: 04015630918904

Distribution Pattern:

US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Voluntary or Mandated:

Voluntary: Firm initiated