Recall Z-1444-2020— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-1444-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-07

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2020-02-07, terminated 2024-05-30. It names one FDA 510(k) clearance: K050231. Product: Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer. 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..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-02-07
Terminated: 2024-05-30
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K050231 — ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSETRoche Diagnostics Corp.·cleared 2005-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.