Beckman Coulter, Inc. Recall 90941
Description: MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Beckman Coulter, Inc. Recall 90941 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0269-2023 |
| Event ID | 90941 |
| Event Description | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 |
| Product Type | Devices |
| 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. |
| Quantity | 53 plates |
| Recall Reason | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. |
| Device Classification | 20221130 |
| Device Code Info | 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 |
| Center Classification Date | 20221118 |
| Recall Initiation Date | 20221003 |
| Recalling Firm | Beckman Coulter, Inc. |
| Initial Notification | Letter |
| Similar To |