Beckman Coulter Inc. recalls Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: T…

Recall date

December 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1674-2020

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.