Recall Z-1815-2025 ยท JHN Turbidimetric Method, Lipoproteins
Beckman Coulter Ireland, Inc.
Apo B Reagent, REF: OSR6143
| Date | May 23, 2025 (initiated Apr 23, 2025) |
| Status | Open, Classified |
| Reason | The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited. |
| Root cause | Error in labeling |
| Action | On April 23, 2025, Beckman Coulter issued a "Urgent Medical Device Recall" Notification to affected consignees via mail and E-Mail. Beckman Coulter asked consignees to take the following actions: 1. If your laboratory is reporting Apo B results generated using the combination of reagent OSR6143, Lot 2631 and calibrator ODR3022, Lot 3000 in mg/dL units, a retrospective review of patient results greater than 77 mg/dL and less than 176 mg/dL is recommended. 2. Discard the value assignment sheet located within each kit of Apo B OSR6143 Lot 2631. 3 Download the updated VAS kit insert from the B |
| Quantity | 2747 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, IN, MD, MI, NJ, NY, OH, OK, OR, PA, TX, VA, WA, WV and the countries of Argentina, Australia, Belarus, Belgium, Bulgaria, Canada, China, Czechia, Egypt, Estonia, France, Germany, Ghana, Greece, Hong Kong, India, Ireland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952466 | OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc., Jun 5, 1995 |