Device product
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Z-1444-2020
Product summary
- Event
- Event 84915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 684
- Official record key
device-enforcement:Z-1444-2020
Official wording
Reason: 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.
Code information: Lot 416245 ***Updated 10/5/20*** 483123 ***Updated 8/5/22*** Additional released lots are subject to the same workaround: 46449, 50474,525510, and 568976
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.