Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Reported: July 31, 2024 Initiated: May 27, 2024 #Z-2428-2024
Product Description
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
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
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2. Recalled by Beckman Coulter Inc.. Units affected: 13,565 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2024. Severity: Moderate. Recall number: Z-2428-2024.
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