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Recall Observatory FDA recall evidence

Device product

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Z-0269-2023

October 03, 2022

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 90941
Status
Ongoing
Classification
Class II
Quantity
53 plates
Official record key
device-enforcement:Z-0269-2023

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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