Recall Z-1112-2025 ยท PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Beckman Coulter Inc.
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
| Date | Feb 5, 2025 (initiated Jan 2, 2025) |
| Status | Open, Classified |
| Reason | Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall letter was sent during the week of December 30, 2024, to the affected customers via first class mail and email. If a passing calibration curve can be generated using the Access PCT reagent lots listed above, no action is needed. If repeated calibration failures with a failure code of Max Iterate are obtained using the Access PCT reagent lots listed above, discontinue using the affected reagent lot number. |
| Quantity | 6,994 US; 10,067 OUS |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Kazakhstan, Korea, Republic of, Malaysia, Mexico, Peru, Philipp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192271 | Access PCT, Access PCT Calibrators Beckman Coulter, Inc., Nov 26, 2019 |