Z-0981-2024 Class II Ongoing
FDA device recall Z-0981-2024 was initiated by Beckman Coulter, Inc. on November 21, 2023 and is designated Class II. 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 Ul… The recall status is ongoing. Affected quantity: 19,125 reagent packs.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- November 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,125 reagent packs
Product Description
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
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.
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.
Code Information
UDI/DI 15099590230623, Lot Numbers: 125533, 125589, 233656, 233919, 234055, 234339, 234388