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
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