Recall archive / FDA device enforcement
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 — FDA record Z-0269-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 3, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
- Reason
- Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 53 plates
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0269-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 30, 2022
- Recall initiation date
- Oct 3, 2022
- Center classification date
- Nov 18, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.