medical Class II Updated 2020-03-11

Roche Diagnostics Operations, Inc. recalls Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the p

Recalled Product

Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

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