Beckman Coulter recalls Access Ultrasensitive Insulin for DxI 9000 analyzers with incorrect unit conversion that could lead to inaccurate blood glucose readings.
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of ¿IU/mL to the International System of Units (SI units) of pmol/L.
Beckman Coulter is recalling Access Ultrasensitive Insulin test kits for the DxI 9000 Access Immunoassay Analyzer due to an incorrect unit conversion factor. This could cause inaccurate blood glucose readings, potentially leading to health risks if not corrected.
The Access Ultrasensitive Insulin assay protocol file (APF) uses an incorrect conversion factor when changing from ¿IU/mL to pmol/L. This error could result in inaccurate blood glucose readings, which might lead to improper diabetes management decisions.
Users of the Access Ultrasensitive Insulin test kits with the specified catalog number and lot numbers are affected. Individuals relying on accurate blood glucose readings for diabetes management are at the highest risk.
Check for the catalog number 33410 and lot numbers 125533, 125589, 233656, 233919, 234055, 234339, or 234388 on the test kit. The product is only used with the DxI 9000 Access Immunoassay Analyzer.
Verify the catalog number and lot numbers on the Access Ultrasensitive Insulin test kit to confirm if it is recalled.
The Access Ultrasensitive Insulin assay protocol file (APF) uses an incorrect conversion factor when converting from ¿IU/mL to pmol/L, which could lead to inaccurate blood glucose readings.
The recall record does not specify a remedy, so check the product details to see if it is affected and contact Beckman Coulter for further instructions.
The recall indicates a potential for inaccurate blood glucose readings, but no specific risk of serious injury is mentioned. The danger level is low_risk.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0981-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0981-2024 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.
