Abbott recalls CELL-DYN Ruby blood analyzers with model 04U42-84 software versions. Using expired reagents can lead to incorrect expiration dates, violating 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 blood analyzers with model number 04U42-84. Using expired reagents can cause the system to show incorrect expiration dates, which may lead to inaccurate test results.
When expired reagents are scanned or manually entered, the system updates the expiration date to current or future dates without warning. This can lead to using expired reagents, which violates operator guidelines and may cause inaccurate test results.
Healthcare facilities using the CELL-DYN Ruby blood analyzer with model 04U42-84 are affected. Users most at risk are those who rely on the device for accurate blood testing.
Check for model number 04U42-84 on the device. The serial numbers listed in the recall include 35939BG through 71710BG. This product was sold with all software versions.
Verify that reagents are within their expiration dates before use to avoid incorrect date updates.
The system changes expiration dates to current or future dates when expired reagents are scanned or manually entered, which violates operator guidelines.
Look for model number 04U42-84 with serial numbers listed in the recall (e.g., 35939BG through 71710BG).
Ensure reagents are within expiration dates before use to prevent incorrect date updates. No return or replacement is required.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1656-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1656-2025 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.
