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Recall Observatory FDA recall evidence

Device 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.

Z-1674-2020

December 13, 2019

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 85137
Status
Terminated
Classification
Class II
Quantity
3,472 units
Official record key
device-enforcement:Z-1674-2020

Official wording

Reason: 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.

Code information: Lot number 20201103T, Expiration Date: 11/3/2020

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.