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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Abbott Laboratories: Alinity hq Analyzer Recalled for Falsely Low Blood Count Results

Agency Publication Date: August 16, 2024
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Summary

Abbott Laboratories is recalling 816 Alinity hq Analyzers due to a software defect that can cause inaccurate blood test results. When specific types of blood tests are run back-to-back, the device may report falsely low red blood cell counts, falsely low hematocrit, and falsely high hemoglobin measurements. Additionally, the analyzer may incorrectly count cell events as basophils, leading to inaccurate white blood cell differentials. These errors could lead to incorrect medical diagnoses or inappropriate treatment for patients.

Risk

The software defect causes the analyzer to provide incorrect data for critical blood parameters like red blood cell counts and basophil levels. This creates a risk of medical mismanagement, where a patient might receive unnecessary treatment or have a serious condition go undetected based on the faulty lab results.

What You Should Do

  1. Identify if your laboratory is using the Alinity hq Analyzer (REF: 09P68-01) by checking the serial number on the device or in your records against the recalled list (e.g., HQ00105 through HQ01246).
  2. Check the software version currently installed on your device; affected versions include 5.7 in the United States and version 5.6 or below for international locations.
  3. Laboratories and healthcare providers should immediately contact Abbott Laboratories or their healthcare representative to discuss the impact on recent test results and to schedule necessary software updates.
  4. Review laboratory protocols to ensure that 'Complete Blood Count with differential and reticulocyte' samples are not immediately followed on the same rack by standard 'CBC+Diff' samples until the software is updated.
  5. For further technical assistance or to report issues, contact Abbott Laboratories directly or reach out to the FDA at 1-888-463-6332 (1-888-INFO-FDA).
  6. Additional information and updates can be found on the FDA medical device recalls website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software update and usage protocol adjustment

How to: Contact your healthcare provider or the manufacturer (Abbott Laboratories) for further instructions on updating software and potential credit or refund options.

Affected Products

Product: Alinity hq Analyzer
Model / REF:
09P68-01
Z-2681-2024
UPC Codes:
380740138851
Lot Numbers (818):
Software Version 5.7 (US)
Software Version 5.6 and below (OUS)
HQ00105
HQ00108
HQ00117
HQ00118
HQ00119
HQ00120
HQ00126
HQ00127
HQ00128
HQ00132
HQ00136
HQ00139
HQ00140
HQ00141
HQ00142
HQ00144
HQ00145
HQ00147
HQ00148
HQ00149
HQ00152
HQ00153
HQ00154
HQ00156
HQ00157
HQ00161
HQ00162
HQ00166
HQ00169
HQ00171
HQ00172
HQ00173
HQ00174
HQ00175
HQ00183
HQ00184
HQ00185
HQ00186
HQ00187
HQ00188
HQ00266
HQ00268
HQ00269
HQ00270
HQ00271
HQ00273
HQ00274
HQ00276

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94958
Status: Active
Manufacturer: Abbott Laboratories
Sold By: Direct sales to diagnostic laboratories; Medical facilities
Manufactured In: United States
Units Affected: 816
Distributed To: New York, Oklahoma, North Carolina

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.