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U.S. Department of Health and Human Services

Class 2 Device Recall Iron Gen.2

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 Class 2 Device Recall Iron Gen.2see related information
Date Initiated by FirmApril 26, 2021
Create DateMay 24, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1675-2021
Recall Event ID 87854
510(K)NumberK951595 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductIRON 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.
Code Information UDI: 04015630918904
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactRoche Customer Support Center
317-521-4343
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce20,468 kits
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJE
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