RecallRadar

FDA Device recall Z-0269-2023

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

On 2022-11-30 the FDA classified a Class II recall of MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 by Beckman Coulter, citing due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0269-2023
ClassificationClass II
Statusongoing
Initiated2022-10-03
Published2022-11-30
Last updated2026-09-13 11:56 UTC
CompanyBeckman Coulter
DistributionUS

Product

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Reason

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

Identifiers

code_info
MicroScan autoSCAN-4 Instrument Catalog Number: B1018-280 UDI-DI Code: 15099590658625 Serial Numbers for new manufactur…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0269-2023%22

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