Instrumentation Laboratory 2023-04-05 Health serious FDA
Health · FDA · Recall #FDA-Z-1306-2023
ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis… Recall
Issued April 5, 2023 · Instrumentation Laboratory
In April 2023, Instrumentation Laboratory recalled the ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
What you should do
- 1 Stop using ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Instrumentation Laboratory to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Instrumentation Laboratory
- Category
- Health
- Recall date
- April 5, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Bra
- Recall number
- FDA-Z-1306-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Instrumentation Laboratory has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.