Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent Recalled by Abbott Laboratories Due to Firm has identified that ARCHITECT SHBG results generated...
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 SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders.
Quantity: 7981 kits
Why Was This Recalled?
Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
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