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FDAFebruary 7, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

07027028190

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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