Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in Recalled by Beckman Coulter Biomedical Division Due to The firm has identified that the Transferrin reagent...
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 Beckman Coulter Biomedical Division directly.
Affected Products
AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
Quantity: 2,754
Why Was This Recalled?
The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mode attributed to Transferrin reagent (OSR6152 / lot 2573) associated with reagent blank shifts for the Reagent 2 (R2), imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. Reagent Blank shifts for R2, imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter Biomedical Division
Beckman Coulter Biomedical Division has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report