Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Analyzers with certain serial numbers and software versions due to potential specific gravity measurement errors. Affected units may not trigger chemistry system flags, leading to inaccurate urine test results.
Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry system flag S3 and may result in erroneous Specific Gravity (SG) results.
Beckman Coulter is recalling certain iChem VELOCITY Urine Chemistry Analyzers because specific gravity settings may not trigger the chemistry system flag S3, which can cause inaccurate urine test results. This issue affects specific serial numbers and software versions listed in the recall.
The device's specific gravity chemistry settings may prevent the trigger of chemistry system flag S3, which can result in erroneous specific gravity (SG) results. This means urine test results might not be accurate, but the risk of serious injury is not described in the recall.
Users of the iChem VELOCITY Urine Chemistry Analyzer with specific serial numbers and software versions listed in the recall are affected. Healthcare providers and labs using these devices may need to verify results.
Check if your iChem VELOCITY Urine Chemistry Analyzer has a serial number or software version listed in the provided list of affected units. The recall includes specific serial numbers and software versions.
Identify your device's serial number and software version to see if it matches the affected list provided in the recall.
The iChem VELOCITY Urine Chemistry Analyzer may not trigger chemistry system flag S3, which can result in erroneous specific gravity (SG) results.
Check your device's serial number and software version against the list of affected serial numbers and software versions provided in the recall.
No action is required if your device's serial number and software version are not listed in the affected list.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0843-2020 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0843-2020 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.
