Lower riskMedical device recall · FDA · Published April 26, 2021
Roche Iron Gen 2 Reagent Cassettes: Inaccurate Test Results Risk
Roche recalls Iron Gen 2 reagent cassettes for inaccurate iron test results on certain analyzers. Affected units may show elevated results or control recovery issues. Consumers should contact Roche for details.
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.
“Roche Iron Gen 2 Reagent Cassettes: Inaccurate Test Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62708-roche-iron-gen-2-reagent-cassettes-inaccurate-test-results-risk. Based on FDA recall #Z-1675-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1675-2021%22&limit=1).
The FDA announced on April 26, 2021, that Roche Diagnostics Operations, Inc. is recalling IRON GEN 2 reagent cassettes due to potential for discrepant elevated results. The recall affects approximately 20,468 kits distributed nationwide.
How to tell if you have it
Brand: Roche
Product: IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
Catalog#: 03183696122
UDI: 04015630918904
Quantity: 20,468 kits
The hazard
Roche received complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 assay on cobas c311, 501, 502, and COBAS Integra 400 plus analyzers.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Recent similar recalls include the Roche cobas pro integrated solutions recall (Jan. 20, 2026), the Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and the Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include the Menopause Test Cassette Recall (Nov. 22, 2025), the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), and the Immunotech Estrone RIA Kit Recall (Dec. 15, 2025).
How to tell if you have this one
Check for the catalog number 03183696122 on the reagent cassette. The product is used for iron testing on Roche/Hitachi cobas c and Integra systems. The unique device identifier (UDI) is 04015630918904.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Roche
Reach out to Roche for specific guidance on affected units and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 50 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1675-2021 (April 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1675-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.