Z-1444-2020Class II

Elecsys CA 19-9, Cat. No. 07027028190 -

Name: Z-1444-2020 Elecsys CA 19-9, Cat. No. 07027028190 -
Creator: Roche Diagnostics Operations, Inc.
Published: 2020-02-07
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2020-02-07 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer on 2020-02-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1444-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-07
Posted: 2020-03-05
Terminated: 2024-05-30
Recalling firm: Roche Diagnostics GmbH
Product: Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Product code: NIG System, Test, Carbohydrate Antigen (Ca19-9), 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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1444-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1444-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-05

Product code NIG

K050231Class IIElecsys Ca 19-9 Immunoassay, Elecsys Ca 19-9 CalsetRoche Diagnostics Corp. / cleared 2005-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)