FDA (Devices) recall action 93724
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or < ) to derive a calculated test as part of result reporting; 4) Res…
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.
Beckman Coulter is recalling 19,125 Access Ultrasensitive Insulin reagent packs due to an incorrect unit conversion factor in the assay protocol file. The error could produce inaccurate insulin test results.