Recall Z-0269-2023 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Beckman Coulter, Inc.
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
| Date | Nov 18, 2022 (initiated Oct 3, 2022) |
| Status | Open, Classified |
| Reason | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.