Beckman Coulter recalls Access 2 Immunoassay System (Catalog 81600N) due to potential minor skin burns from reagent contact during pipettor alignment. Affected units have specific serial numbers.
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Beckman Coulter is recalling its Access 2 Immunoassay System (Catalog Number 81600N) because improper use could cause minor skin burns. This is a minor hazard that doesn't require immediate stoppage but needs careful handling to avoid injury.
The device's reagent storage interface board (B79917) can cause minor skin burns if the pipettor alignment tool contacts it during use. This happens when the tool touches the board while aligning the pipettor.
Users of the Access 2 Immunoassay System for medical testing are affected. Laboratory technicians and healthcare professionals using the device are most at risk due to frequent handling.
Check for the Access 2 Immunoassay System with Catalog Number 81600N. Affected units have serial numbers in ranges: 570005-570043, 570047-570049, and other specific ranges listed in the recall notice.
Review your Access 2 Immunoassay System's serial numbers to see if they match the affected ranges listed in the recall.
No, the recall states only a potential for minor skin burns, not serious injury.
Check your serial numbers against the affected ranges provided in the recall notice. If affected, contact Beckman Coulter for guidance.
The recall does not mention a fix or remedy; users are advised to check their serial numbers and contact the manufacturer if affected.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0308-2018 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0308-2018 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.