Primus Corporation recalls specific Ultra2 Resolution Variants System models due to lack of pre-market approval. Affected units may pose health risks if used without regulatory clearance.
The product did not receive pre-market approval or clearance.
Primus Corporation is recalling certain Ultra2 Resolution Variants System models because they were not approved by regulators before being sold. Using these devices without proper clearance could lead to health risks.
The product was sold without receiving pre-market approval from regulatory authorities. This means it may not meet safety and performance standards, potentially causing health risks if used in medical settings.
Medical professionals and lab users who own or use the recalled Ultra2 Resolution Variants System models are most at risk. The recall affects specific units with listed serial numbers.
Check if your Ultra2 Resolution Variants System has the listed serial numbers in the recall notice. The affected units include specific analyzer units with serial numbers starting with 100242 through 100802.
Look for the serial numbers on the analyzer unit, which range from 100242 to 100802 as listed in the recall notice.
The product was sold without receiving pre-market approval from regulatory authorities, which may pose health risks if used without proper clearance.
The recall notice does not specify a remedy, so contact Primus Corporation directly for guidance.
The affected models include the Ultra2 Resolution Variants Analyzer with serial numbers from 100242 to 100802 as listed in the recall notice.
We’ve drafted a message you can send Primus to request your refund or repair — edit it as you like.
Subject: Recall Z-0321-2021 — Primus Primus Hello, I own a Primus that is covered by recall Z-0321-2021 from Primus. 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.
