Abbott recalls CELL-DYN Ruby lab equipment with software that may change expired reagent dates to current/future without warning. Use expired reagents against operator guidelines.
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Abbott is recalling CELL-DYN Ruby lab equipment because its software can incorrectly update expired reagent dates to current or future dates without alerting users. Using expired reagents violates lab safety guidelines and could lead to inaccurate test results.
The software may change expiration dates of reagents to current or future dates when scanned or manually entered, without warning the user. This means expired reagents could be used in tests, which violates operator guidelines and may cause inaccurate results.
Lab technicians and healthcare facilities using CELL-DYN Ruby equipment with model 08H67-10 and all software versions. Those handling reagents for medical testing are most at risk.
Check for model number 08H67-10 on the CELL-DYN Ruby equipment. The serial numbers listed in the recall include 35405BG through 55828BG and others. This equipment was sold with all software versions.
Verify that reagent expiration dates are not being updated to current or future dates in the software.
Yes, if your CELL-DYN Ruby has model number 08H67-10 and all software versions, as listed in the recall.
Use expired reagents is against operator guidelines; contact Abbott for guidance on proper reagent handling.
Check the model number on your CELL-DYN Ruby equipment; affected units have model 08H67-10 with serial numbers listed in the recall.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1654-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1654-2025 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.
