Beckman Coulter recalls specific DxH reagent kits and cleaners produced between June 1, 2021 and September 30, 2021 due to potential temperature excursions affecting product effectiveness.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Beckman Coulter is recalling certain DxH reagent kits and cleaners made between June 1 and September 30, 2021. These products may have been exposed to temperatures that could reduce their effectiveness, though no injuries have been reported.
The products were potentially exposed to higher temperatures during shipping or storage between June 1 and September 30, 2021. This could affect their effectiveness in laboratory tests, but the recall does not mention any injuries or serious health risks.
Healthcare facilities that purchased these specific reagent kits and cleaners between June 1 and September 30, 2021. Laboratory staff using these products are most at risk if they rely on the reagents for accurate testing.
Check for the product names: 'COULTER DxH Diff Pack Reagent (Catalog #628020)', 'COULTER DxH Cleaner (Catalog #628023)', or the DxH 500 Series Lyse and Cleaner products. These were sold between June 1 and September 30, 2021.
Verify the catalog numbers and dates of purchase to confirm if your product is affected.
The recall record does not mention any injuries.
The recalled products include COULTER DxH Diff Pack Reagent (Catalog #628020), COULTER DxH Cleaner (Catalog #628023), and DxH 500 Series Lyse and Cleaner products.
The products were made and shipped between June 1 and September 30, 2021.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1629-2022 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1629-2022 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.
