Recall Z-0032-2026 ยท CGR Radioimmunoassay, Cortisol
Beckman Coulter Inc.
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
| Date | Oct 2, 2025 (initiated Aug 4, 2025) |
| Status | Open, Classified |
| Reason | On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays. |
| Root cause | Software Design Change |
| Action | On 8/4/2025, recall notices were mailed and/or emailed to customers who were asked to do the following: Check your software version, select Menu - About page. - For Clinical Analyzers running software version 1.3.3 or 1.3.4, if this issue occurs, you will need to place a new order for the CC combination test, - Select Home - Sample List task indicator, then select Active in the upper left corner of the Sample List to display samples "In Progress". - Program the CC combination tests for these "In Progress" samples using a new rack and Sample ID, apply the new barcode, then load the rack onto th |
| Quantity | 116 |
| Distribution | Internationally distribution to the countries of Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242190 | Access Cortisol; DxC 500i Clinical Analyzer Beckman Coulter, Inc., Mar 5, 2025 |