Beckman Coulter recalls UIBC reagent lot 2690 for potential erroneous low patient results. Affected units sold with catalog number OSR61205 and UDI 15099590011925.
The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
Beckman Coulter is recalling a specific lot of UIBC reagent (lot 2690) because it may produce inaccurate low results in patient tests. This could lead to incorrect medical decisions if used without replacement.
The reagent may produce erroneously high patient results at the low end of the linear range. This could lead to incorrect medical decisions if the results are used for diagnosis or treatment.
Healthcare professionals using Beckman Coulter AU analyzers with the specific UIBC reagent lot 2690. Patients receiving tests using this reagent may be at risk of incorrect results.
Check for the catalog number OSR61205 and unique device identifier (UDI) 15099590011925. The affected lot is 2690 with an expiration date of October 1, 2021.
Look for the lot number 2690 on the reagent packaging or label.
The manufacturer states that this specific lot (2690) may produce erroneous results. Use only reagents from other lots as directed.
Check for catalog number OSR61205 and UDI 15099590011925. The affected lot is 2690 with an expiration date of October 1, 2021.
The recall does not specify a remedy. Contact Beckman Coulter for guidance on safe handling or replacement.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-3028-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-3028-2020 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.
