FDA-Device2024-02-14Class II
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Affected count
19,125 reagent packs
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0981-2024More Beckman Coulter, Inc. recalls
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