device · product 1 of 1
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
- Recall number
- Z-2428-2024
- Initiated
- May 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 13,565 units
App-derived interpretation
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
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
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
Code information
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
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.