The Recall Desk
HighFDA (Devices)·Z-1655-2025·Announced 2025-04-30

Abbott CELL-DYN Ruby analyzer silently accepts expired reagents

Abbott's CELL-DYN Ruby analyzer has a software defect where expired reagents cause it to change their expiration dates without alerting operators, risking inaccurate test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall involves a risk-of-harm defect: use of expired reagents could compromise test accuracy in clinical diagnostics. While no illnesses or injuries have been reported, the silent nature of the defect increases patient safety risk by preventing operator detection of the problem.

Plain-English summary

Abbott Laboratories is recalling the CELL-DYN Ruby hematology analyzer (Model 08H67-13, all software versions) due to a software defect in how the device handles expired reagents. When expired reagents are scanned or manually entered into the system, the device automatically changes the expiration date to the current or future date without notifying the operator.

This behavior violates the guidelines in the Operator's Manual for reagent use. Expired reagents may not perform as intended, which could result in inaccurate test results. Because the system does not alert operators, users may unknowingly rely on test data generated with expired reagents, potentially compromising clinical decision-making.

The CELL-DYN Ruby analyzer is used in clinical and laboratory settings for blood cell analysis. The recall affects devices distributed nationwide across 48 U.S. states and Puerto Rico, as well as internationally to more than 100 countries.

Operators of affected analyzers should be aware of this defect and implement careful verification procedures to prevent use of expired reagents. Users are advised to contact Abbott Laboratories for information regarding this recall and potential remediation options.

The recalled product

Product
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Manufacturer
Abbott Laboratories
Category
Medical Device — Hematology Analyzer
Hazard
  • expired-reagents
  • software-defect
  • diagnostic-error-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI 00380740017170 SN: 34036BG96

Distribution

Distributed nationwide across the United States.

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