Beckman Coulter, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0269-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Product Classification:

Class II

Date Initiated: October 3, 2022

Date Posted: November 30, 2022

Recall Number: Z-0269-2023

Event ID: 90941

Reason for Recall:

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

Status: Ongoing

Product Quantity: 53 plates

Code Information:

MicroScan autoSCAN-4 Instrument Catalog Number: B1018-280 UDI-DI Code: 15099590658625 Serial Numbers for new manufactured: 400495, 400496, 400497, 400498, 400499, 400500, 400503, 400504, 400506, 400507, 400508, 400509 400510, 400511, 400512, 400513, 400514, 400515, 400516, 400517, 400518, 400519, 400520, 400521 400522, 400523, 400524, 400528 Diffuser Plate component Part Number: P/N 5639-0001 Serial Numbers for previously install base: 6685, 6786, 6826, 7480, 8449, 9911, 10405, 10446, 10886, 11219, 11295, 11424, 11815, 11841, 20351, 20403, 300003, 300175, 400058, 400080, 400234, 400340, 400354, 400373, 400444

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated