Z-0269-2023 Class II Ongoing
FDA device recall Z-0269-2023 was initiated by Beckman Coulter, Inc. on Oct 3, 2022 and is designated Class II. Reason for recall: Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. The recall status is ongoing. Affected quantity: 53 plates.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 30, 2022
- Initiation Date
- Oct 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 plates
Product Description
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 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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0269-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026