# FDA recall Z-2488-2023

> **Beckman Coulter Inc.** · Class II · device recall initiated 2023-07-12.

## Product

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

## Reason for recall

Lipemic interference failed to meet the performance specification listed within the IFU.

## Distribution

US: AL	AR	AZ	CA	CO	CT	DC	DE	FL	GA	IA	IL	IN	KS	KY	LA	MA	MD	MI	MN	MO	MS	NC	ND	NE	NJ	NM	NY	OH	OK	OR	PA	RI	SC	SD	TN	TX	UT	VA	WA	WI	WV  OUS: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, C¿te d'Ivoire, Croatia, Cura¿ao, Cyprus, Czechia, Denmark, Ecuador, Egypt, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uruguay, Viet Nam, Yemen.

## Key facts

- **Recall number:** Z-2488-2023
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-12
- **Report date:** 2023-09-06

- **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-2488-2023

## Citation

> AI Analytics. FDA recall Z-2488-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2488-2023. Source: US FDA. Licensed CC0.

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