Health Canada — Medical Devices · Canada · 2023-03-08 · Type II
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Reported risk: Werfen is releasing a mandatory test library upgrade on the ACL Elite/Elite Pro (test library 02.05.00). This is a follow up to phase 1 of the recall for of the removal of Hemosil ® Liquid Anti-Xa (pn 0020302600 and 0020302601) on the ACL Elite/Elite Pro. This mandatory library release, among other features, removes the test definition for Hemosil Liquid Anti-Xa (pn 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments. Recall start date: February 3, 2023
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