FDA recall Z-1674-2020

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.

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.

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.

Key facts

Status

Terminated

Initiation date

2019-12-13

Report date

2020-04-15

Termination date

2021-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1674-2020