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Roche Diagnostics Operations, Inc. Recall 87854

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.

Roche Diagnostics Operations, Inc. Recall 87854 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1675-2021
Event ID87854
Event DescriptionIRON 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 TypeDevices
DistributionUS 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.
Quantity20,468 kits
Recall ReasonRoche 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.
Device Classification20210602
Device Code InfoUDI: 04015630918904
Center Classification Date20210524
Recall Initiation Date20210426
Recalling FirmRoche Diagnostics Operations, Inc.
Initial Notification Letter
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