Day

November 12, 2025
12
Nov

FDA Recall: Hq analyzer results in system not applying appropriate flagging to results when saturation is present

November 12, 2025
Company: Abbott Laboratories Date of Enforcement Report: 11/12/2025 Class: II PRODUCT: Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No Recall Number: Z-0489-2026 REASON: Software issue for hq analyzer results in...
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