FDA Medical Device Recalls (openFDA)
Roche Diagnostics Operations, Inc.: Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
- Recall number
- Z-1444-2020
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Product
- Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
- Status
- Terminated
- Initiated
- 2020-02-07
- Posted
- 2020-03-05
- Terminated
- 2024-05-30
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On February 7, 2020, the firm issued an Urgent Medical Device Correction letter to affected customers. Customers were informed of the product issue and given two options for CA 19-9 testing until another reagent lot is available for the cobas e 801 module: 1) Use a different Roche platform for testing, or 2) Implement a workaround, described in detail in the customer letter. The letter also provided instructions for receiving credit depending on which option was elected. Roche will notify customers when a new lot of CA 19-9 reagent for the cobas e 801 is available for ordering. ***Updated 10/5/20*** On 10/2/20, the firm issued an updated letter to customers to communicate an expansion to the recall. An additional lot was added to the recall scope.
- Quantity
- 684
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K050231"]
- PMA numbers
- not on file
- Product code
- NIG
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28