Z-2428-2024Class II

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

Name: Z-2428-2024 Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Creator: Beckman Coulter Inc.
Published: 2024-05-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-05-27 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 on 2024-05-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2428-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-27
Posted: 2024-07-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Reason for recall: 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 tag: manufacturing process
FDA 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 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.
Quantity in commerce: 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, 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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2428-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2428-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-24

Product code CFN

K073487Class IIOlympus Igm ReagentOlympus America, Inc. / cleared 2008-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)