Beckman Coulter, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0981-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 21, 2023

Date Posted: February 14, 2024

Recall Number: Z-0981-2024

Event ID: 93724

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 19,125 reagent packs

Code Information:

UDI/DI 15099590230623, Lot Numbers: 125533, 125589, 233656, 233919, 234055, 234339, 234388

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated