FDA recall Z-0269-2023

Beckman Coulter, Inc. · Class II · device

Product

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Reason for recall

Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

Distribution

Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI MS, MT, NC, NE, PA, SC, TX WA, WI, and WV. The countries of Chile, Germany, Indonesia, Italy, Japan, Mexico, Peru, Portugal, South Africa, Spain, United Kingdom of Great Britain and Northern Ireland, and Uruguay.

Key facts

Status: Ongoing
Initiation date: 2022-10-03
Report date: 2022-11-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: West Sacramento, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0269-2023