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.
FDA Recall Z-1675-2021 · Posted None
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Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusOpen, Classified
Product CodeJJE
Date Initiated2021-04-26
Product Quantity20,468 kits
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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