Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the… recallZ-1444-2020 · Roche Diagnostics Operations, Inc. · initiated Feb 7, 2020
Class II Terminated All recalls posted in March 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1444-2020
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 7, 2020
- Posted by the FDA
- Mar 5, 2020
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 684
- Product code
- NIG
- FDA submissions
- K050231
- 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.
Product description
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
2 devices cleared under K050231 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Elecsys CA 199 Immunoassay 11776193122Roche Diagnostics GmbH · SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER32 reports
- Elecsys CA 19-9 07027028190Roche Diagnostics GmbH · SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER32 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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