Recall Z-1674-2020 ยท LIE Reagent/Device, Inoculum Calibration
Beckman Coulter Inc.
Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution antimicrobial susceptibility test.
| Date | Apr 6, 2020 (initiated Dec 13, 2019) |
| Status | Terminated |
| Reason | Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results. |
| Root cause | Nonconforming Material/Component |
| Action | On 12/13/2019, the firm notified its customers via "Urgent Medical Device Recall" letter informing customers of the recall and its potential to cause false-susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results. The notification instructs customers to take the following actions: 1. Discontinue use and discard any remaining inventory of the incorrect wands with lot number 13.LAG.1 that may be found with the Prompt Inoculation System-D lot number 20201103T. 2. The notification letter also instructs customers to share the |
| Quantity | 3,472 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, NE, NY, NC, ND, OH, OK, PA, SD, TN, TX, UT, WV, WI, WY and countries of Canada, China, Japan, Paraguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820299 | PROMPT INOCULATION SYSTEM 3M Company, Mar 15, 1982 |