Class 2 Device Recall MicroScan PROMPT Inoculation SystemD

• Date Initiated by Firm: December 13, 2019
• Date Posted: April 06, 2020
• Recall Status: Terminated on April 30, 2021
• Recall Number: Z-1674-2020
• Recall Event ID: 85137
• 510(K)Number: K820299
• Product Classification: Reagent/device, inoculum calibration - Product Code LIE
• Product: 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.
• Code Information: Lot number 20201103T, Expiration Date: 11/3/2020
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Jose Untalan; 714-961-5321
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 contents of the letter with lab/medical directors to determine the need to review previous patient and quality control test results. 3. In order to assure you have received the important communication, please respond within 10 days in one of the following ways: - Electronically, if you received this communication via email - Manually, complete and return the enclosed Response Form 4. If you have any questions regarding this notice, please contact the firm's Customer Support Center: - Via our website, http://www.beckmancoulter.com/customersupport/support - Via phone, call 1-800-677-7226 in the US 5. For customers in the US, if you need replacement products: - Complete the attached "Replacement Order Form" and email the form to askbeckman@beckman.com or fax to (866) 294-7850 or Call Client Services at (800) 526-3821
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LIE and Original Applicant = 3M COMPANY