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Instrumentation Laboratory Recall: ACL ELITE Refurbished-Analyzer designed specifically fo

Instrumentation Laboratory Recall: ACL ELITE Refurbished-Analyzer designed specifically fo is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Instrumentation Laboratory; Product: ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagul

Recalling firmInstrumentation Laboratory
ProductACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
Reason for recallRemoves the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China, Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India,
Recall initiated20230203
Recall numberZ-1306-2023
Categorydevice
StateMA
CountryUnited States

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