Abbott recalls CELL-DYN Ruby blood analyzers with model 08H67-13 software versions. Using expired reagents may 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 08H6:13 software. Using expired reagents can cause the system to show incorrect expiration dates, which may lead to improper testing results.
The system changes expiration dates to current or future dates when expired reagents are scanned or manually entered. This happens without warning, potentially leading to incorrect test results if expired reagents are used.
Healthcare professionals using CELL-DYN Ruby analyzers with model 08H67-13 software. Those who run tests with expired reagents may face inaccurate results.
Check for model number 08H67-13 on the analyzer. The software version is all versions. This product was sold by Abbott Laboratories.
Verify that reagents are within their expiration dates before use.
The system changes expiration dates to current or future dates when expired reagents are scanned or manually entered, which violates operator guidelines.
The recall does not require immediate action; check reagent expiry dates before use.
The recall does not provide a fix; users must ensure reagents are not expired.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1655-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1655-2025 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.
