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Beckman Coulter Inc. recalls Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: Th
Recalled April 15, 2020 · FDA recall Z-1674-2020 · Beckman Coulter
Hazard
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 Class II
Units
3,472 units
Sold at
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.
Description
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.
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.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →