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.
This recall is currently active, issued April 26, 2021. It was issued by Roche Diagnostics Operations, Inc..
- Recall Initiated
- April 26, 2021
- Recall Number
- Z-1675-2021
- Quantity
- 20,468 kits
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
UDI: 04015630918904
Root Cause
Process control
Action Taken
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.