Lower riskMedical device recall · FDA · Published February 7, 2020
Roche Elecsys CA 19-9 Reagent May Give False High Results - Recall
Roche recalls specific lots of Elecsys CA 19-9 reagent for possible false high results affecting pancreatic cancer monitoring. Affected lots include 416245 and others listed. No action needed for most users.
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.
“Roche Elecsys CA 19-9 Reagent May Give False High Results - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65872-roche-elecsys-ca-19-9-reagent-may-give-false-high. Based on FDA recall #Z-1444-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1444-2020%22&limit=1).
The FDA announced on Feb. 7, 2020, that Roche Diagnostics Operations, Inc. is recalling Elecsys CA 19-9 reagent due to non-reproducible elevated results that may affect clinical interpretation. The recall involves Lot 416245 and several additional lots distributed nationwide.
How to tell if you have it
Brand: Roche
Product: Elecsys CA 19-9
Catalog No.: 07027028190
Lot codes: 416245, 483123, 46449, 50474, 525510, 568976
Distribution: US Nationwide in AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI
The hazard
The firm received an increased number of complaints concerning non-reproducible elevated results for one lot of Elecsys CA 19-9 reagent. These "high flyers" may affect clinical interpretation.
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has had 32 other recalls on record since July 2, 2019. Recent similar recalls include the Roche cobas pro integrated solutions recall (Jan. 20, 2026), the Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and the Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include the Siemens Atellica CH A1c_E Test Recall (June 8, 2026), the Immunotech Estrone RIA Kit Recall (Dec. 15, 2025), and the Siemens Atellica CH Urine Albumin Recall (July 6, 2026).
How to tell if you have this one
Check the lot number on the reagent vial. Affected lots include 416245, 46449, 50474, 525510, and 568976. The product is sold under the brand name Roche.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the reagent vial to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 21 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maine, Massachusetts, Michigan, New Hampshire, New Jersey, New York, North Carolina, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 4.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1444-2020 (February 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1444-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.