Recall Z-1308-2023 — MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
U.S. FDA — Device Enforcement · United States · 2023-02-01 · Class II
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Reported risk: Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.
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