Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 recallZ-2428-2024 · Beckman Coulter Inc. · initiated May 27, 2024

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number

Z-2428-2024

Status

Open, Classified

Initiated by the company

May 27, 2024

Posted by the FDA

Jul 24, 2024

Recalling firm

Beckman Coulter Inc.

Quantity

13,565 units

Product code

CFN

FDA submissions

K073487

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, 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.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• AU OSR61173

  Beckman Coulter, Inc. · Method, Nephelometric, Immunoglobulins (G, A, M)
  1 recall0 reports