BEUDAMED
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    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    FDA Enforcement
    Class III ·Terminated·Lin-Zhi International Inc·May 8, 2019

    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 31, 2021