Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alinity s System software version2.8.0 Recalled by Abbott Laboratories, Inc Due to Software error associated with the immunoassay analyzer wash...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Laboratories, Inc directly.
Affected Products
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
Quantity: 306 units
Why Was This Recalled?
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott Laboratories, Inc
Abbott Laboratories, Inc has 31 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report