Roche Diagnostics Operations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1444-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 7, 2020

Date Posted: March 11, 2020

Recall Number: Z-1444-2020

Event ID: 84915

Reason for Recall:

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.

Status: Terminated

Product Quantity: 684

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.

Voluntary or Mandated:

Voluntary: Firm initiated