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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 and ARCHITECT Processing Modules Recalled for Unlabeled Latex

Agency Publication Date: January 9, 2024
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Summary

Approximately 3,447 Abbott Alinity and ARCHITECT processing modules used in medical laboratories are being recalled because they contain a dry natural rubber (latex) component that is not disclosed on the product labeling. These automated immunoassay and chemistry analyzers were distributed across most U.S. states and in Brazil. Consumers and laboratory staff should contact their healthcare provider or Abbott Laboratories for further instructions regarding this equipment defect.

Risk

The presence of unlabeled dry natural rubber (latex) in the device's subcomponents poses a risk of allergic reactions to patients or laboratory staff who have latex sensitivities. Exposure to these components can trigger symptoms ranging from skin irritation to severe respiratory distress in highly sensitive individuals.

What You Should Do

  1. Check the model and list number of your processing module to see if it is one of the affected versions: Alinity i (03R65-01), Alinity c (03R67-01), or ARCHITECT c4000 (02P24-01, 02P24-02, 02P24-40, 01R24-56, 01R25-56).
  2. Verify your specific system's serial number against the extensive list provided by the manufacturer; for example, Alinity i systems such as AI01413 through AI26261 and Alinity c systems AC01225 through AC06280 are affected.
  3. If your facility uses these modules, identify any personnel or patients with known latex allergies who may come into contact with the equipment.
  4. Contact your healthcare provider or Abbott Laboratories directly at 1-888-463-6332 to receive updated labeling or further instructions regarding the management of these devices.
  5. Call the FDA's consumer hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

📋Other Action

Lab labeling and risk assessment

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Alinity i Processing Module
Model / REF:
03R65-01
Lot Numbers (992):
AI01413
AI01414
AI01434
AI01447
AI01467
AI01468
AI01599
AI01607
AI01796
AI01823
AI01824
AI01827
AI01830
AI01837
AI01839
AI01873
AI01874
AI01991
AI02055
AI02056
AI02057
AI02058
AI02109
AI02110
AI02111
AI02117
AI02199
AI02201
AI02208
AI02232
AI02234
AI02288
AI02292
AI02293
AI02345
AI02368
AI02391
AI02392
AI02423
AI02433
AI02444
AI02448
AI02493
AI02514
AI02536
AI02555
AI02569
AI02592
AI02594
AI02595
Product: Alinity c Processing Module
Model / REF:
03R67-01
Lot Numbers (1040):
AC01225
AC01226
AC01256
AC01257
AC01263
AC01264
AC01273
AC01274
AC01275
AC01356
AC01357
AC01358
AC01503
AC01504
AC01505
AC01506
AC01507
AC01508
AC01509
AC01510
AC01512
AC01513
AC01518
AC01521
AC01522
AC01523
AC01553
AC01554
AC01561
AC01566
AC01582
AC01584
AC01585
AC01588
AC01589
AC01591
AC01593
AC01594
AC01603
AC01604
AC01605
AC01606
AC01608
AC01630
AC01644
AC01666
AC01667
AC01668
AC01669
AC01670
Product: ARCHITECT c4000 Processing Module
Model / REF:
02P24-01
02P24-02
02P24-40
01R24-56
01R25-56
Lot Numbers (897):
C400911
C402913
C460004
C460033
C460055
C460066
C460082
C460158
C460200
C460375
C460385
C460396
C460397
C460408
C460410
C460422
C460435
C460439
C460523
C460532
C460588
C460728
C460767
C460797
C460798
C460800
C460826
C460827
C460830
C460832
C460833
C460834
C460846
C460849
C460857
C460868
C460875
C460886
C460927
C460928
C460939
C460958
C460993
C461042
C461092
C461093
C461100
C461105
C461112
C461122

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93355
Status: Active
Manufacturer: Abbott Laboratories
Sold By: Medical laboratories; Hospitals
Manufactured In: United States
Units Affected: 3 products (1,325 systems; 1,127 systems; 995 systems)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

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 · 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.