ADVIA Centaur CA 19-9 recall
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…
Why was ADVIA Centaur CA 19-9 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)00630414574028(10)55972535(17)20240914; (01)00630414574028(10)55973535(17)20240914 Kit Lot: 55972535, 55973535
- Product
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Distribution
- Worldwide - US Nationwide distribution
- Recall date
- September 18, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)