Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARCHITECT CA 19-9XR Reagent Kit Recalled by Abbott Laboratories Due to The six ARCHITECT CA 19-9XR reagent lots are...
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 Abbott Laboratories directly.
Affected Products
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
Quantity: 316 kits - USA, 8,356 kits ROW
Why Was This Recalled?
The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift and will test within range.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Laboratories
Abbott Laboratories has 124 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report