Z-1674-2020 Class II Terminated
FDA device recall Z-1674-2020 was initiated by Beckman Coulter Inc. on December 13, 2019 and is designated Class II. 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… The recall status is terminated (terminated April 30, 2021). Affected quantity: 3,472 units.
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