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.
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling 20,468 Iron Gen 2 reagent cassettes (Catalog #03183696122) used with cobas c311, 501, and 502 analyzers and COBAS Integra 400 plus analyzer for in vitro iron testing. The recall was initiated because Roche received multiple complaints about the assay producing increased control recovery and discrepant elevated results. The affected product was distributed nationwide across all 50 states plus the District of Columbia, Guam, and Puerto Rico, with the UDI 04015630918904.
The source document does not specify a remedy or recommended action for consumers or healthcare facilities affected by this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 20,468 kits Lot/code info: UDI: 04015630918904
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.