Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs Recalled by ORTHO-CLINICAL DIAGNOSTICS Due to Customers may receive positively biased results when using...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ORTHO-CLINICAL DIAGNOSTICS directly.
Affected Products
VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
Quantity: 475
Why Was This Recalled?
Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ORTHO-CLINICAL DIAGNOSTICS
ORTHO-CLINICAL DIAGNOSTICS has 14 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report