Z-0492-2020 Class II Ongoing
FDA device recall Z-0492-2020 was initiated by Beckman Coulter Inc. on Nov 9, 2018 and is designated Class II. Reason for recall: Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred… The recall status is ongoing. Affected quantity: 83 automate systems.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 27, 2019
- Initiation Date
- Nov 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 automate systems
Product Description
AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
Reason for Recall
Beckman Coulter has identified a case where a customer using the microltiterplate kit option without a sorting drive encountered a cross-contamination of samples when a connection time-out occurred between the system and Laboratory Information System (LIS) .
Distribution Pattern
US: NY, VA OUS: Austria Belgium Czech Republic France Germany Israel Italy Lithuania Mayotte Romania Slovakia South Africa Spain Sweden Switzerland United Kingdom
Code Information
All units containing software Version(s) 4.1.1 and up
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0492-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026