Z-1674-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- December 13, 2019
- Termination Date
- April 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,472 units
Product Description
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 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.
Code Information
Lot number 20201103T, Expiration Date: 11/3/2020