ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
Reported: April 5, 2023 Initiated: February 3, 2023 #Z-1306-2023
Product Description
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
Reason for Recall
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Details
- Recalling Firm
- Instrumentation Laboratory
- Units Affected
- 1 unit US
- Distribution
- Worldwide 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, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Kossovo, Latvia, Lebanon, Lithuania, Malawi, Malaysia, Mexico, Philippines, Poland, Romania, Russian Fed., Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Zimbabwe.
- Location
- Bedford, MA
Frequently Asked Questions
What product was recalled? ▼
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R. Recalled by Instrumentation Laboratory. Units affected: 1 unit US.
Why was this product recalled? ▼
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2023. Severity: Moderate. Recall number: Z-1306-2023.
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