Beckman Coulter recalls AU/DxC AU Chemistry Transferrin reagent OSR6152 (lot 2573) due to potential control failures and inaccurate patient test results. Affected units may show erratic quality control or incorrect high/low patient results.
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.
Beckman Coulter is recalling AU/DxC AU Chemistry Transferrin reagent OSR6152 (lot 2573) because it may cause control failures and inaccurate patient test results. This could lead to erroneous high or low patient results if used in medical testing equipment.
The reagent may cause control failures and inaccurate patient test results due to instability. This can lead to erratic quality control readings and incorrect high or low patient results when used in medical testing equipment.
Laboratory users who have the AU/DxC AU Chemistry Transferrin reagent OSR6152 with lot number 2573 are affected. Medical professionals using this reagent for patient testing are most at risk of inaccurate results.
Check for the reagent name 'AU/DxC AU Chemistry Transferrin REF: OSR6152' with lot number 2573. The expiration date is August 1, 2024.
Look for lot number 2573 on the reagent packaging to confirm if it is affected.
The reagent may cause control failures and inaccurate patient test results due to instability, leading to erratic quality control readings and incorrect high or low patient results.
The official recall notice does not specify a remedy or action steps for affected reagents.
The recall indicates potential issues with accuracy, but the official notice does not state that the reagent is unsafe for use.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0309-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0309-2024 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
