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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1675-2021 |
| Event ID | 87854 |
| Event 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. |
| Product Type | Devices |
| 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 |
| Recall Reason | 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. |
| Device Classification | 20210602 |
| Device Code Info | UDI: 04015630918904 |
| Center Classification Date | 20210524 |
| Recall Initiation Date | 20210426 |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| Initial Notification | Letter |
| Similar To |