Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: Th

FDA device recall Z-1674-2020 · posted 2020-04-06 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LIE

Quantity affected

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

Date initiated

2019-12-13

Date posted

2020-04-06

Date terminated

2021-04-30

Location

Brea, CA

Related 510(k) clearances