Recall Z-0981-2024 ยท CFP Radioimmunoassay, Immunoreactive Insulin
Beckman Coulter, Inc.
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
| Date | Feb 5, 2024 (initiated Nov 21, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/21/2023 via US mail and email. The notices explained the issues with the devices, the impact on test results, and requested the following actions be taken: Issue 1 - Configure the Access Ultrasensitive Insulin assay to the system default units (IU/mL). Refer to the appropriate system manuals for instructions. To manually convert concentrations to SI units (pmol/L), multiply IU/mL by a multiplication factor of 7.0. Issue 2 - If the DxI 9000 Access Immunoassay Analyzer is connected to a host system, you |
| Quantity | 19,125 reagent packs |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953084 | ACCESS ULTRASENSITIVE INSULIN ASSAY Bio-Rad Laboratories, Inc., Sep 25, 1995 |