FDA-Device2020-03-11Class II
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Roche Diagnostics Operations, Inc.
Hazard
The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.
Sold states
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI.
Affected count
684
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1444-2020Don't want to check this manually?
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