Z-1675-2021 Class II Ongoing
FDA device recall Z-1675-2021 was initiated by Roche Diagnostics Operations, Inc. on April 26, 2021 and is designated Class II. 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 Integ… The recall status is ongoing. Affected quantity: 20,468 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 2, 2021
- Initiation Date
- April 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,468 kits
Product 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.
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 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.
Code Information
UDI: 04015630918904