Recall Z-2428-2024 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Beckman Coulter Inc.
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
| Date | Jul 24, 2024 (initiated May 27, 2024) |
| Status | Open, Classified |
| Reason | LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal |
| Root cause | Process control |
| Action | On May 23, 2024, Beckman Coulter issued a "Urgent Medical Device Recall" notification via: xxx. 1. Update the LIH Influence Check settings for Lipemia on AU480, AU680, DxC 500 AU and DxC 700 AU analyzers if they are enabled for IgM. 2. To determine if the LIH Influence Check is enabled for IgM and to update your Lipemia setting, see customer communication. 3. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or Medical Director to determine if a review of previous patient test results should be conducted. . Discontinuance or disposal of this product is |
| Quantity | 13,565 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of Albania, Algeria, Argentina, Australia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073487 | OLYMPUS IGM REAGENT Olympus America, Inc., Feb 11, 2008 |