MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
- Company
- Beckman Coulter, Inc.
- Recall Initiated
- October 3, 2022
- Posted
- November 18, 2022
- Recall Number
- Z-0269-2023
- Quantity
- 53 plates
- Firm Location
- West Sacramento, CA
Reason for Recall
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
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.
Lot / 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
Root Cause
Nonconforming Material/Component
Action Taken
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