Abbott recalls CELL-DYN Ruby analyzers with model 08H67-01 software. Expired reagents scanned or manually entered may change expiration dates to current or future dates without warning, 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 08H67-01. Using expired reagents with these devices can cause the system to incorrectly update expiration dates, potentially leading to inaccurate test results. This issue occurs when expired reagents are scanned or manually entered into the device.
When expired reagents are scanned or manually entered into the CELL-DYN Ruby device, the system changes the expiration date to current or future date without notifying the user. This violates the Operator's Manual guidelines and could result in inaccurate test results if expired reagents are used.
Healthcare professionals using CELL-DYN Ruby analyzers with model 08H67-01 software. The risk is low as expired reagents are not actively causing harm but could lead to inaccurate test results if not properly managed.
Check for model number 08H67-01 with all software versions. The product has serial numbers listed in the recall notice (e.g., 30039BG, 34021BG, etc.).
Verify that reagents are within their expiration dates before use. If expired, do not scan or manually enter them into the CELL-DYN Ruby device.
The CELL-DYN Ruby device changes expiration dates to current or future dates when expired reagents are scanned or manually entered, which violates the Operator's Manual guidelines.
Your device is affected if it has model number 08H67-01 with any software version, as listed in the recall notice (e.g., serial numbers like 30039BG, 34021BG, etc.).
No return is required. The recall focuses on proper use of reagents to avoid incorrect results.
We’ve drafted a message you can send Abbott Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1652-2025 — Abbott Laboratories Abbott Laboratories Hello, I own a Abbott Laboratories that is covered by recall Z-1652-2025 from Abbott Laboratories. 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.
