# FDA recall Z-2428-2024

> **Beckman Coulter Inc.** · Class II · device recall initiated 2024-05-27.

## Product

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

## 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 Ki

## Key facts

- **Recall number:** Z-2428-2024
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-27
- **Report date:** 2024-07-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2428-2024

## Citation

> AI Analytics. FDA recall Z-2428-2024. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-2428-2024. Source: US FDA. Licensed CC0.

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