medical Class II Updated 2024-02-14

Beckman Coulter, Inc. recalls Access Ultrasensitive Insulin only used on the DxI 9000 Acce

Recalled Product

Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 15099590230623, Lot Numbers: 125533, 125589, 233656, 233919, 234055, 234339, 234388
View official government recall

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