Beckman Coulter, Inc. 2024-02-14 Health serious FDA
Health · FDA · Recall #FDA-Z-0981-2024
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer,… Recall
Issued February 14, 2024 · Beckman Coulter, Inc.
In February 2024, Beckman Coulter, Inc. recalled the Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of ¿IU/mL to the International System of Units (SI units) of pmol/L.
What you should do
- 1 Stop using Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter, Inc. 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
- Beckman Coulter, Inc.
- Category
- Health
- Recall date
- February 14, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary,
- Recall number
- FDA-Z-0981-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Beckman Coulter, Inc. has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.