CLASS II ONGOING Device recall · Reported 30 Nov 2022 · FDA Enforcement Report

MicroScan autoSCAN-4 Instrument recalled by Beckman Coulter

Beckman Coulter is recalling MicroScan autoSCAN-4 Instrument, distributed nationwide in the US. The recall was initiated on 3 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMicroScan 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

Quantity recalled53 plates

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0269-2023
FDA event ID: 90941
Recalling firm: Beckman Coulter, West Sacramento, CA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Oct 2022
FDA classified: 18 Nov 2022
Reported: 30 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Oct 2022	Recall initiated by company
18 Nov 2022	Classified by FDA	+46 days
30 Nov 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Where it was distributed

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.

Nationwide Alaska Florida Iowa Idaho Michigan Mississippi Montana North Carolina Nebraska Pennsylvania South Carolina Texas Washington Wisconsin West Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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