Z-0269-2023Class II

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Name: Z-0269-2023 MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Creator: Beckman Coulter, Inc.
Published: 2022-10-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-10-03 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 on 2022-10-03. FDA classified it as Class II and gives the reason as "Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0269-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-03
Posted: 2022-11-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Product code: JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Reason for recall: Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: During the week of 10/03/2022, an Urgent Medical Device Recall letter was sent via email and a hardcopy via standard postal mail. The letter is informing customers that the diffuser plates used with the MicroScan autoSCAN-4 were incorrectly manufactured with the locator notch in the upper right corner with the shiny side up. Customers are instructed to follow steps outlined in Attachment 1 of the notice: -If they confirm the diffuser plate was manufactured with the locator notch in the upper right corner with the shiny side up, follow the steps in Attachment 1, Part II to reverse this shield so that it is installed frosted side up, the notch will now be on the left. - If they confirm the diffuser plate was manufactured with the locator notch in the upper right corner with the diffuser plate frosted side up, then no further action is required. - Ensure the diffuser plate continues to be installed with frosted side up (as described in Attachment 1, Part II ) when performing maintenance each day before first use per MicroScan autoSCAN-4 Instrument Guide and until you receive replacement. - They may choose to display Attachment 1 next to your AS4 to ensure this work around is performed correctly until replacement is available. - Contact Customer Technical Support 800 677-7226 option 1 for replacement of the diffuser plate (P/N 5639-0001). - Once the replacement is received, discard the diffuser plate in use, install the new diffuser plate and create a Water Blank File with the newly placed shield to ensure optimization of the panel reads. - Check their P/N 5639-0001 inventory, if their diffuser plate was manufactured with the locator notch in the upper right corner with the shiny side up, contact Customer Technical Support 800 677- 7226 option 1 for replacement. For questions, contact Customer Technical Support at http://www.beckmancoulter.com or call 800-677-7226 option 1 or Client Services 800-526-3821
Quantity in commerce: 53 plates
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0269-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0269-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-30	2022-11-18

Product code JJQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)