—#180153

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.

FDA product code: LIE — Reagent/Device, Inoculum Calibration
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K820299
Affected lot / code info: Lot number 20201103T, Expiration Date: 11/3/2020

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-12-13
Posted by FDA: 2020-04-06
Terminated: 2021-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180153. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.