Abbott recalls CELL-DYN Ruby blood analyzers with model 08H67-03 software that may show current dates for expired reagents, risking inaccurate test results. Affected units include specific serial numbers.
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 08H67-03 software that may incorrectly display current or future dates for expired reagents. This could lead to inaccurate test results if expired reagents are used, as the system doesn't warn users.
The system changes expiration dates to current or future dates when expired reagents are scanned or manually entered, without alerting the user. This means expired reagents could be used in tests, potentially leading to incorrect blood analysis results.
Healthcare facilities using the CELL-DYN Ruby blood analyzer with model 08H67-03 software. Laboratory staff and patients using these analyzers may be at risk of inaccurate test results if expired reagents are scanned or entered.
Check for the model number 08H67-03 and software version listed in the product description. Affected units have specific serial numbers listed in the recall notice, including many starting with 34006BG96 through 54981BG96.
Verify that reagents are not expired before use. The system may show current dates for expired reagents without warning.
The CELL-DYN Ruby blood analyzer may change expiration dates to current or future dates when expired reagents are scanned or manually entered, without notifying the user. This could lead to inaccurate test results.
Model number 08H67-03 with all software versions. Affected units have specific serial numbers listed in the recall notice.
Check for the model number 08H67-03 and software version. Affected units have serial numbers starting with 34006BG96 through 54981BG96 as listed in the recall notice.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1653-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1653-2025 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.
