Abbott recalls Alinity i Processing Module REF 03R65-01 due to dry natural rubber (latex) subcomponent not being labeled. Affected units have specific serial numbers listed in the recall notice.
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Abbott is recalling certain Alinity i Processing Modules (REF 03R65-01) because they contain a dry natural rubber (latex) subcomponent that isn't labeled as such. This could cause allergic reactions in sensitive individuals, but the recall doesn't specify a risk of injury or harm.
The devices contain a dry natural rubber (latex) subcomponent that is not labeled as containing latex. This could cause allergic reactions in individuals sensitive to latex, but the recall does not indicate a risk of injury or harm.
Users of the Alinity i Processing Module REF 03R65-01 with the specific serial numbers listed in the recall notice are affected. People with latex allergies may be at higher risk of allergic reactions.
Check if your Alinity i Processing Module has the serial numbers listed in the recall notice (AI01413 through AI25542). The product is a fully automated immunoassay analyzer used for medical testing.
Verify if your device has a serial number in the list provided in the recall notice (AI01413 to AI25542).
The recall states the device contains a dry natural rubber (latex) subcomponent not labeled as such, but it does not indicate a risk of injury or harm. The product is safe for most users.
No, the recall does not require stopping use. The product is safe for most users, but those with latex allergies should be cautious.
Check if your serial number is in the list provided in the recall notice. If it is, you may want to contact Abbott for further guidance.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0680-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0680-2024 from Abbott. 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.
