Iron Gen.2 recallZ-1675-2021 · Roche Diagnostics Operations, Inc. · initiated Apr 26, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
On 04/26/2021, Roche issued an Urgent Medical Device Correction notice to customer via letter notifying them of issues regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c 311, 501, and 502 analyzers and on the COBAS INTEGRA 400 plus analyzer.
Recall details
- Recall number
- Z-1675-2021
- Status
- Open, Classified
- Initiated by the company
- Apr 26, 2021
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 20,468 kits
- Product code
- JJE
- FDA submissions
- K951595
- 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, WA, WI, WV, WY.
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.
Code information (models, lots, serial numbers)
UDI: 04015630918904
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Iron Gen.2 3183696122Roche Diagnostics GmbH · Photometric method, iron (non-heme)1 recall16 reports
Product lines
Other devices under the same FDA submission
11 devices cleared under K951595 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Creatinine Jaffe Gen.2 08057532190Roche Diagnostics GmbH · ALKALINE PICRATE, COLORIMETRY, CREATININE17 reports
- Creatinine Jaff Gen2 6407137190Roche Diagnostics GmbH · ALKALINE PICRATE, COLORIMETRY, CREATININE13 reports
- Total Protein Gen2 3183734190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN11 reports
- Phosphate (Inorganic) ver.2 03183793122Roche Diagnostics GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus11 reports
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 20764949322Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot6 reports
- Ethanol Gen2 3183777190Roche Diagnostics GmbH · ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD5 reports
- Total Protein Gen2 5171385190Roche Diagnostics GmbH · BIURET (COLORIMETRIC), TOTAL PROTEIN5 reports
- Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation 5850819190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot4 reports
- Aspartate Aminotransferase acc to IFCC with pyridoxal phosphate activation 4467493190Roche Diagnostics GmbH · Nadh oxidation/nad reduction, ast/sgot3 reports
- Ethanol Gen.2 08057630190Roche Diagnostics GmbH · ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD2 reports
- Ethanol Gen.2 08445672190Roche Diagnostics GmbH · ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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