—#208284

Product

Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

FDA product code: CFN — Method, Nephelometric, Immunoglobulins (G, A, M)
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K073487
Affected lot / code info: UDI: 15099590011598/ All Lots: 2548/Exp. 2024-06-01, 2549/Exp.2024-10-01, 2550/Exp. 2024-11-01, 2551/Exp. 2025-04-01, 2552/Exp. 2025-07-01, 2553/Exp. 2025-10-01, 2554/ Exp. 2026-03-01

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 not necessary. . Retain a copy of this letter as it serves as current labelling. . Per the IFU, avoid highly Lipemia samples when using the IgM assay. 4. Please complete the response form within 10 days in one of the following ways: - Electronically, if you received this communication via email./Manually, complete and return the enclosed Response Form. 5. If you have any questions regarding this notice, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com/By phone: call 1-800-854-3633 in the United States. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China (DX), Colombia, Croatia, Cyprus, Czechia, Denmark, Ecuador, Egypt, Estonia, France, Georgia, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Province of China, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Viet Nam, Yemen.

Timeline

Recall initiated: 2024-05-27
Posted by FDA: 2024-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208284. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.