Lower riskMedical device recall · FDA · Published July 26, 2024
Siemens Atellica CA 19-9 Test May Give False High Results in Some Samples
Siemens Healthcare recalls Atellica IM CA 19-9 tests that may show falsely high results near the upper limit of normal for some Asian Pacific samples. This could affect cancer screening accuracy.
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
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Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc.333 Coney St · East Walpole, MA 02032-1516
✎ GovInfoNow plain-language explainer
Siemens Healthcare is recalling Atellica IM CA 19-9 test kits that may give falsely high results for some samples near the upper limit of normal, particularly in Asian Pacific populations. This could lead to inaccurate cancer screening results if the test is used without the recall fix. Read more at govinfonow.com/recall/54391-siemens-atellica-ca-19-9-test-may-give-false-high.
“Siemens Atellica CA 19-9 Test May Give False High Results in Some Samples.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54391-siemens-atellica-ca-19-9-test-may-give-false-high. Based on FDA recall #Z-3100-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3100-2024%22&limit=1).
The FDA announced on July 26, 2024, that Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 (50 Test) in vitro diagnostic kits. The agency cited a positive bias for some samples around the CA 19-9 upper limit of normal as the hazard.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated
UPC: 00630414598178
Kit Lot: 55974535, 55975535
The hazard
According to the FDA, the recalled kits exhibit a positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m compared to previous lots. The sample bias observed was greatest in the Asia Pacific sample population and is less pronounced for sample results above a concentration of 110 U/mL.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls include the Siemens Atellica CH RCRP Test (Aug. 17, 2026) and the Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include the Magellan LeadCare II Blood Lead Test Kits (March 13, 2026), the Cepheid Xpert BCR-ABL Ultra Test Kits (Oct. 30, 2025), and the Magellan LeadCare Ultra Blood Lead Test Kit (March 13, 2026).
How to tell if you have this one
Check for the kit lot number 55974535 or 55975535 on the Atellica IM CA 19-9 test kit. The product was sold with the serial number starting with SMN: 10995490.
Brand
Siemens Healthcare
Product
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution
Recall number
Product, codes & lots
Quantity
Z-3100-2024
Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490; UDI-DI: (01)00630414598178(10)55974535(17)20240914 Kit Lot: 55974535, 55975535
—
Z-3101-2024
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489; UDI-DI: (01)00630414598161(10)55977535(17)20240914 Kit Lot: 55977535
—
Z-3102-2024
Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239; UDI-DI: (01)00630414293516(10)56434535(17)20240914 Kit Lot: 56434535
—
Z-3103-2024
ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239; UDI-DI: (01)00630414574257(10)55970535(17)20240914; (01)00630414574257(10)55971535(17)20240914 Kit Lot: 55970535, 55971535
—
Z-3104-2024
ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491244; UDI-DI: (01)00630414574028(10)55972535(17)20240914; (01)00630414574028(10)55973535(17)20240914 Kit Lot: 55972535, 55973535
—
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the kit lot number 55974535 or 55975535 on the test kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
No, this recall is for potential false high results in some samples, not a safety hazard. The test remains safe to use but may give inaccurate results.
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-3100-2024 (July 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3100-2024 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.