Company: Abbott Laboratories Date of Enforcement Report: 12/22/2023 Class II PRODUCT Alinity ci-series System Control Module, REF: 03R70-01 Recall Number: There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to...Read More
Company: Abbott Laboratories Date of Enforcement Report: 12/22/2023 Class II PRODUCT Alinity ci-series System Control Module, REF: 03R70-01 Recall Number: Z-0613-2024 REASON: There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests...Read More
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